BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH-XS PRE-FILLED SYRINGES

    MDR report key: 19654452 · Received July 2, 2024

    Report

    Report Number
    9616657-2024-00020
    Event Type
    Malfunction
    Date Received
    July 2, 2024
    Date of Event
    June 12, 2024
    Report Date
    September 18, 2024
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    NGT
    UDI-DI
    00382903065721
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306572 AND LOT NUMBER 3250005. THE REVIEW DID NOT REVEAL ANY NON-CONFORMANCES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. TO AID IN THE INVESTIGATION OF THIS ISSUE, THREE (3) PHYSICAL SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY TEAM. ALL THREE SAMPLES WERE STILL IN THEIR ORIGINAL BLISTER PACKAGING. ONE (1) SAMPLE HAD A HOLE WITHIN THE TOP WEB. REGARDING THE HOLE IN THE TOP WEB, IT IS MOST LIKELY THAT THIS RESULTED FROM THE NESTING OF THE BLISTER PACKAGES. IF THE BLISTER PACKAGES ARE NOT NESTED CORRECTLY IT COULD RESULT IN DAMAGE TO THE TOP WEB WHEN THEY ARE PACKAGED OFF INTO THE SHELF CARTONS. BASED ON THE PREVENTIVE MEASURES IN PLACE, WE BELIEVE THIS WAS AN ISOLATED INCIDENT WITH AN UNLIKELY CHANCE OF RECURRENCE. AT THIS TIME, FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD POSIFLUSH-XS PRE-FILLED SYRINGES HAVE A HOLE IN THE PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: HOLE IN THE PACKAGING WHEN DID THE INCIDENT OCCUR? BEFORE USE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570962 BD POSIFLUSH-XS PRE-FILLED SYRINGES SALINE VASCULAR ACCESS FLUSH NGT BECTON, DICKINSON AND CO. 3250005 00382903065721

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown