BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH¿ NORMAL SALINE SYRINGE

    MDR report key: 17027753 · Received May 30, 2023

    Report

    Report Number
    1911916-2023-00358
    Event Type
    Malfunction
    Date Received
    May 30, 2023
    Date of Event
    April 29, 2023
    Report Date
    May 6, 2023
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NGT
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER#: 306595 AND LOT NUMBER#: 2090054. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD POSIFLUSH¿ NORMAL SALINE SYRINGE CRACKS WERE FOUND IN THE BARREL OF THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "AFTER THE INFUSION WAS FINISHED, THE PATIENT WAS GIVEN 10ML PRE-FLUSHING AND SEALING TUBE. BEFORE SEALING THE TUBE, THE PRE-FLUSHING WAS CHECKED WITHOUT DAMAGE OR AIR LEAKAGE, WHICH COULD BE USED NORMALLY. DURING THE SEALING PROCESS, THE AIR FLOW WAS SUDDENLY HEARD, AND THE INJECTION WAS STOPPED IMMEDIATELY TO CHECK THE PIPE, AND CRACKS WERE FOUND IN THE PRE-FLUSHING TUBE BODY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1130778 BD POSIFLUSH¿ NORMAL SALINE SYRINGE SALINE, VASCULAR ACCESS FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 2090054

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown