BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML REG PR SALINE 10ML FILL

    MDR report key: 8570502 · Received May 1, 2019

    Report

    Report Number
    1911916-2019-00429
    Event Type
    Malfunction
    Date Received
    May 1, 2019
    Date of Event
    April 12, 2019
    Report Date
    May 17, 2019
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NGT
    UDI-DI
    30382903065463
    PMA / PMN Number
    K161552
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: ONE SAMPLE WAS RECEIVED. IT HAS RESIDUES OF DRIED BLOOD FROM THE LUER TO THE BOTTOM OF THE RUBBER STOPPER. THIS INDICATES THE SYRINGE WAS USED TO DRAW BLOOD. THE PLUNGER ROD- RUBBER STOPPER SEPARATION IS 3/32¿, THEREFORE FAILURE MODE IS VERIFIED. THE POSIFLUSH PRODUCT IS DESIGNED TO FLUSH THE LINES, NOT TO DRAWING BLOOD. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED WITH ZERO DEFECTS FOUND. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TWO SYRINGE 10ML REG PR SALINE 10ML FILL EXPERIENCED A DEFORMED STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 306546 BATCH NO.: 8172883. IT WAS REPORTED THAT THE PLUNGER SEPARATED FROM THE BLACK RUBBER STOPPER.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO SYRINGE 10ML REG PR SALINE 10ML FILL EXPERIENCED A DEFORMED STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 306546, BATCH NO.: 8172883. IT WAS REPORTED THAT THE PLUNGER SEPARATED FROM THE BLACK RUBBER STOPPER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361196 SYRINGE 10ML REG PR SALINE 10ML FILL SALINE, VASCULAR ACCESS FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 8172883 30382903065463

    Patients

    Seq Age Sex Outcome Treatment
    1 Other