jueves, 28 de noviembre de 2019

FDA MedWatch: Blood Administration Sets by B. Braun Medical: Recall


MedWatch Safety Alert was added to the FDA Medical Devices Recall webpage. 

TOPIC: Blood Administration Sets by B. Braun Medical: Recall - Due to Potential for Leakage at the Joint Between the Blood Filters and Tubing

AUDIENCE: Laboratory, Risk Manager, Health Professional

ISSUE: B. Braun Medical initiated a voluntary recall of twenty-two (22) lots of Blood Administration Sets. The recalled blood administration sets are used to administer blood from a container to a patient's vascular system through an IV catheter inserted into a vein or central venous catheter.

B. Braun identified through complaints and internal discrepancies the potential for leakage at the joint between the blood filters and tubing of these blood administration sets. Blood set leakage may result in delay in therapy due to the need to replace the set and blood product or result in the potential for microorganisms to enter the circulatory system creating a risk of bloodstream infection. To date there have been no reports of serious injury or death.

Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
  • Complete and submit the report online.
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the form, or submit by fax to 1-800-FDA-0178.

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