BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL TIP 1ML

    MDR report key: 10797516 · Received November 5, 2020

    Report

    Report Number
    1911916-2020-01015
    Event Type
    Malfunction
    Date Received
    November 5, 2020
    Date of Event
    October 14, 2020
    Report Date
    November 11, 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
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 0140469. 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, TWO PHOTOS WERE PROVIDED. THE PICTURES SHOW A SYRINGE WITH SOLUTION. IN ONE OF THE PHOTOS IT IS POSSIBLE TO SEE A PIECE OF PLASTIC INSIDE THE SYRINGE AND IT APPEARS A PIECE OF A PLUNGER ROD THUMB PRESS AREA. THE CAUSE FOR THIS DEFECT COULD HAVE RESULTED DURING THE ASSEMBLY PROCESS WHERE A JAM OCCURRED, DAMAGING THE A PLUNGER ROD CAUSING THE PIECE OF PLASTIC TO FALL INTO THE BARREL. THE ASSEMBLY AREA WAS INSPECTED FOR ANY PIECES OF PLASTIC ON THE FLOOR OR ON THE EQUIPMENT; NOTHING WAS OBSERVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 50ML LL TIP 1ML HAD FOREIGN MATTER IN THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309653 BATCH NO: 0140469   IT WAS REPORTED THAT A SHARD OF PLASTIC WAS NOTICED WITHIN THE SYRINGE.   EVENT DESCRIPTION PER EMAIL STATES: TECHNICIAN NOTICED A SHARD OF PLASTIC WITHIN THE SYRINGE. SEE ATTACHED PHOTOS. IT APPEARS TO BE A BROKEN PIECE OFF THE ROUND END USED TO PULL THE PLUNGER UP AND DOWN.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 50ML LL TIP 1ML HAD FOREIGN MATTER IN THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309653 BATCH NO: 0140469. ¿ IT WAS REPORTED THAT A SHARD OF PLASTIC WAS NOTICED WITHIN THE SYRINGE. ¿ EVENT DESCRIPTION PER EMAIL STATES: TECHNICIAN NOTICED A SHARD OF PLASTIC WITHIN THE SYRINGE. IT APPEARS TO BE A BROKEN PIECE OFF THE ROUND END USED TO PULL THE PLUNGER UP AND DOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1254901 SYRINGE 50ML LL TIP 1ML PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 309653 0140469 30382903096535

    Patients

    Seq Age Sex Outcome Treatment
    1