BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML LL EUROGRAPHICS

    MDR report key: 11236254 · Received January 27, 2021

    Report

    Report Number
    1213809-2021-00042
    Event Type
    Malfunction
    Date Received
    January 27, 2021
    Date of Event
    December 28, 2020
    Report Date
    March 11, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903009121
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D4: MEDICAL DEVICE LOT#: D4: MEDICAL DEVICE EXPIRATION DATE: 2025-02-28. D10: DEVICE AVAILABLE FOR EVAL? YES. D10: RETURNED TO MANUFACTURER ON: 2021-02-24. H4: DEVICE MANUFACTURE DATE: 2020-03-02. INVESTIGATION SUMMARY: ONE 10ML SYRINGE IN AN OPENED BLISTER PACK FROM BATCH: 0062708 (P/N: 300912) WAS RECEIVED AND EVALUATED. IT WAS OBSERVED THE PLUNGER ROD WAS IN THE BOTTOM OUT POSITION AND THE STOPPER WAS WEDGED BETWEEN THE RETAINING RING AND BARREL WALL. THE JAMMED STOPPER CONDITION WAS REJECTABLE PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE JAMMED STOPPER DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 10ML LL EUROGRAPHICS PLUNGER WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SYRINGE WITH PLUNGER MALFORMATION, NEVER SEEN BEFORE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 10ML LL EUROGRAPHICS PLUNGER WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SYRINGE WITH PLUNGER MALFORMATION, NEVER SEEN BEFORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135415 SYRINGE 10ML LL EUROGRAPHICS PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 0062708 00382903009121

    Patients

    Seq Age Sex Outcome Treatment
    1