BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ SYRINGE WITH BD LUER-LOK¿ TIP

    MDR report key: 7101469 · Received December 8, 2017

    Report

    Report Number
    1911916-2017-00346
    Event Type
    Malfunction
    Date Received
    December 8, 2017
    Date of Event
    November 16, 2017
    Report Date
    January 11, 2018
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    00382903096534
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. "MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7180554. MEDICAL DEVICE EXPIRATION DATE: 06/30/2022. DEVICE MANUFACTURE DATE: 06/29/2017. MEDICAL DEVICE LOT #: 7255837. MEDICAL DEVICE EXPIRATION DATE: 08/31/2022. DEVICE MANUFACTURE DATE: 09/12/2017. MEDICAL DEVICE LOT #: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. " A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    ONE SAMPLE WAS RECEIVED IN THE (B)(4) PLANT FOR EVALUATION. LEAKAGE WAS NOTED THEREFORE FAILURE MODE IS VERIFIED. DHR WAS COMPLETED AND NO DEFECTS WERE FOUND. NO QUALITY NOTIFICATIONS WERE ISSUED FOR THIS BATCH CONCLUSION: CONFIRMED COMPLAINT. ROOT CAUSE-LEAKAGE CAN BE CAUSED BY THE INTERACTION BETWEEN THE BARREL INSIDE DIAMETER, THE STOPPER OUTSIDE DIAMETER, AND PLUNGER ROD BAYONET OUTSIDE DIAMETER AND FORCES APPLIED DURING USE. THE SYRINGE IS MORE LIKELY TO LEAK WHEN FORCES ARE APPLIED TO THE PLUNGER ROD WHEN FULLY EXTENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD¿ SYRINGE WITH BD LUER-LOK¿ TIP LEAKED FLUID FROM SYRINGE BARREL PAST THE FIRST RIB ON THE STOPPER. FOUND BEFORE USE. NO SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    880581 BD¿ SYRINGE WITH BD LUER-LOK¿ TIP PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL SEE H.10. 00382903096534

    Patients

    Seq Age Sex Outcome Treatment
    1 Other