BEUDAMED
    FDA Adverse Event Death Summary report: N

    BD POSIFLUSH¿ PRE-FILLED SALINE SYRINGE

    MDR report key: 15991944 · Received December 15, 2022

    Report

    Report Number
    9616657-2022-00048
    Event Type
    Death
    Date Received
    December 15, 2022
    Date of Event
    November 25, 2022
    Report Date
    February 1, 2023
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    NGT
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1196818. MEDICAL DEVICE EXPIRATION DATE: 30-JUN-2024. DEVICE MANUFACTURE DATE: (B)(6) 2021. MEDICAL DEVICE LOT #: 1251978. MEDICAL DEVICE EXPIRATION DATE: 31-AUG-2024. DEVICE MANUFACTURE DATE: (B)(6) 2021.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 01-DEC-2022. H6: INVESTIGATION SUMMARY: TO AID IN THE INVESTIGATION OF THIS ISSUE, SIX (6) 10ML SYRINGES AND SIX (6) 5ML SYRINGES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. ALL OF THE TWELVE (12) SYRINGES WERE RECEIVED IN THEIR ORIGINAL, UNOPENED BLISTER PACKAGING. HOWEVER, ONLY FOUR (4) OF THE SYRINGES BELONGED TO THE LOT NUMBERS REPORTED IN THIS EVENT. UNFORTUNATELY, TESTING WAS NOT CONDUCTED ON THE RETURNED SAMPLES, AS THEY WERE NOT CONTROLLED/HANDLED APPROPRIATELY DURING THE SHIPMENT RETURN PROCESS. THE RETURNED SAMPLES WERE LOOSE WITHIN A COURIER BAG OUTSIDE OF THEIR ORIGINAL SECONDARY PACKAGING (SHELF CARTON), SO IT COULD NOT BE DETERMINED IF THE STERILITY BARRIER OF THE PACKAGE HAD BEEN BREACHED OR DAMAGED IN TRANSIT. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306582 AND BATCH NUMBERS 1196818 AND 1251978. THE REVIEW DID NOT REVEAL ANY NON-CONFORMANCES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED INCIDENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A DEATH WHILE USING BD POSIFLUSH¿ PRE-FILLED SALINE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT DIED DUE TO SEPSIS WHICH INITIATE AN ENVIRONMENTAL SCREENING FOR THE PATIENT CARE SETTING INCLUDING POSIFLUSH. PATIENT DIED DUE TO SEPSIS WHICH INITIATE A COMPLETE ENVIRONMENTAL SCREENING FOR SETTING FOR THE UNITS INCLUDING THE PREFILLED SYRINGES (POSIFLUSH 10 ML XS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A DEATH WHILE USING BD POSIFLUSH¿ PRE-FILLED SALINE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT DIED DUE TO SEPSIS WHICH INITIATE AN ENVIRONMENTAL SCREENING FOR THE PATIENT CARE SETTING INCLUDING POSIFLUSH. PATIENT DIED DUE TO SEPSIS WHICH INITIATE A COMPLETE ENVIRONMENTAL SCREENING FOR SETTING FOR THE UNITS INCLUDING THE PREFILLED SYRINGES (POSIFLUSH 10 ML XS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2570464 BD POSIFLUSH¿ PRE-FILLED SALINE SYRINGE PREFILLED SALINE SYRINGE NGT BECTON, DICKINSON AND CO. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death