BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL TIP 1ML

    MDR report key: 10492104 · Received September 3, 2020

    Report

    Report Number
    1911916-2020-00846
    Event Type
    Malfunction
    Date Received
    September 3, 2020
    Date of Event
    August 15, 2020
    Report Date
    August 19, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    30382903096535
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S ADDRESS IS UNKNOWN. (B)(6) HAS BEEN USED AS A DEFAULT. (B)(4). INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 1760575. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. TO AID IN THE INVESTIGATION OF THIS INCIDENT, 2 PICTURE SAMPLES WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THROUGH EXAMINATION OF THE RETURNED SAMPLES, THE SYRINGE HAS SCALE MARKINGS MISSING. INVESTIGATION CONCLUSION: OUR QUALITY TEAM WILL CONTINUE TO MONITOR THE MANUFACTURING PROCESS FOR THIS DEFECT AND OTHER EMERGING TRENDS. ROOT CAUSE DESCRIPTION: THE CAUSE OF THIS DEFECT COULD HAVE RESULTED DURING THE SYRINGE ASSEMBLY PRINTING PROCESS WHERE THE MACHINE RAN OUT OF INK. THIS WOULD RESULT IN NO MARKINGS PRINTING ON THE SYRINGE, AND THE DEFECT WENT UNDETECTED DURING THE NEXT PROCESS. RATIONALE: FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 50 ML LL TIP 1 ML WAS MISSING SCALE MARKINGS. THIS WAS DISCOVERED ON 4 OCCASIONS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309653, BATCH NO: 0062316. IT WAS REPORTED THAT: SYRINGE WAS MISSING INCREMENT ML MARKINGS. EVENT DESCRIPTION PER EMAIL STATES: VERBIAGE RECEIVED, I FOUND 3 OF THESE WITH NO LABEL PRINTED ON THEM. I LEFT THIS ONE IN THE PACKAGING. ALL FROM THE SAME LOT NUMBER. THE REST OF THE SYRINGES FROM THIS LOT ALL APPEAR TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    951163 SYRINGE 50ML LL TIP 1ML PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 309653 0062316 30382903096535

    Patients

    Seq Age Sex Outcome Treatment
    1 Other