BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE

    MDR report key: 8311221 · Received February 6, 2019

    Report

    Report Number
    9616657-2019-00112
    Event Type
    Injury
    Date Received
    February 6, 2019
    Date of Event
    December 2, 2018
    Report Date
    March 5, 2019
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    NGT
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: THE NON-CONFORMANCES WERE REVIEWED FOR THIS BATCH, AND THERE WAS NO RECORD OF NON-CONFORMANCE WHICH COULD CONTRIBUTE TO THE COMPLAINT VERBATIM REPORTED BY THE CUSTOMER. NO SAMPLE AVAILABLE FOR TESTING. BASED ON THE INFORMATION PROVIDED, IT IS MORE PROBABLE THAN NOT THAT THE SYMPTOMS DESCRIBED MAY BE AN ALLERGIC REACTION; HOWEVER, IT IS HIGHLY IMPROBABLE THAT THIS REACTION WAS PRODUCED BY THE NORMAL SALINE IN THE BD POSIFLUSH PRODUCT. DURING THE PERIOD 2017-2019, THERE ARE NO OTHER ADVERSE CUSTOMER COMPLAINT TRENDS FOR THE COMPLAINT CATEGORY OF ALLERGIC REACTION, APART FROM FRESENIUS KABI UK. THERE ARE NO KNOWN ALLERGIES TO NORMAL SALINE, EITHER TOPICAL OR WITHIN THE BODY. IT IS MOST LIKELY THAT WHATEVER FLUID WAS IN THE IV LINE PRIOR TO FLUSHING CONTAINED INADEQUATELY FLUSHED MEDICATION OR GLUCOSE FROM PREVIOUS TREATMENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE WAS USED AND THE PATIENT HAD A REACTION. THE PATIENT APPEARED TO BE BREATHLESS WITH SWELLING TO BOTH LEGS. NO MEDICAL INTERVENTION WAS REPORTED.

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8179538, MEDICAL DEVICE EXPIRATION DATE: 2021-06-30, DEVICE MANUFACTURE DATE: 2018-06-28. MEDICAL DEVICE LOT #: 8185572, MEDICAL DEVICE EXPIRATION DATE: 2021-06-30, DEVICE MANUFACTURE DATE: 2018-07-04. MEDICAL DEVICE LOT #: 8242797, MEDICAL DEVICE EXPIRATION DATE: 2021-08-31, DEVICE MANUFACTURE DATE: 2018-08-30. (B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE WAS USED AND THE PATIENT HAD A REACTION. THE PATIENT APPEARED TO BE BREATHLESS WITH SWELLING TO BOTH LEGS. NO MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105662 BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE SALINE FLUSH NGT BECTON, DICKINSON AND CO. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other