BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH XS/SF

    MDR report key: 21247081 · Received January 27, 2025

    Report

    Report Number
    9616657-2025-00002
    Event Type
    Malfunction
    Date Received
    January 27, 2025
    Date of Event
    January 10, 2025
    Report Date
    February 18, 2025
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    NGT
    UDI-DI
    00382903065721
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 4050231. THE REVIEW DID NOT REVEAL ANY POSSIBLE NON-CONFORMANCES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS INCIDENT. AS NEITHER PICTURE NOR PHYSICAL SAMPLES WERE AVAILABLE FOR RETURN, A THOROUGH SAMPLE ANALYSIS COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, WE WERE UNABLE TO REPRODUCE THE REPORTED DEFECT AND UNABLE TO DETERMINE AN EXACT CAUSE. IF THE SAMPLE BECOMES AVAILABLE, ADDITIONAL FINDINGS MAY BE POSSIBLE. 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. B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD POSIFLUSH-XS / SF LEAKAGE PAST STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKY PISTON. DESCRIPTION OF PRODUCT: SYRINGE SALINE XS P/FLUSH 10ML 30EA/BX 8BX/CA LOT OR S/N: (B)(6). COMPLAINT CATEGORY: LEAKING. 17 JAN: DESCRIPTION OF THE COMPLAINT: ACCORDING TO THE REPORT WE RECEIVED FROM THE CLIENT, THE PLUNGER OF THE SYRINGE WAS LEAKING LIQUID. PATIENT INJURY: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607589 BD POSIFLUSH XS/SF SALINE VASCULAR ACCESS FLUSH NGT BECTON, DICKINSON AND CO. 4050231 00382903065721

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown