BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 30ML LL BNS

    MDR report key: 12351689 · Received August 20, 2021

    Report

    Report Number
    1911916-2021-00865
    Event Type
    Malfunction
    Date Received
    August 20, 2021
    Date of Event
    July 7, 2021
    Report Date
    August 13, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    00382903056187
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE LOT #: ACTUAL LOT NUMBER IS UNKNOWN, HOWEVER THE CUSTOMER SUSPECTS LOT 0100616 (MFG: (B)(6) 2020 EXP: 03/31/2025) INVESTIGATION SUMMARY: IT WAS REPORTED THE SYRINGE WAS MISSING NUMBERS AND HAD A DAMAGED TIP. TO AID IN THE INVESTIGATION, ONE SAMPLE WITH NO PACKAGING BLISTER AND THREE PHOTOS WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED. THE SYRINGE BARREL IS DAMAGED AND HAS NO SCALE PRINTED. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THE THREE PHOTOS PROVIDED SHOW THE SAMPLE RECEIVED. THESE DEFECTS CAN OCCUR DURING THE PRINTING PROCESS. A JAM MAY HAVE INDUCED THE DAMAGE TO THE SYRINGE AND THE MISSING PRINT. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 301033, LOT NUMBER 0100616. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. VERIFICATION OF PROCESSES WAS PERFORMED FINDING SETTINGS, ALIGNMENT AND PRODUCT FLOW ACCEPTABLE. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED SYRINGE 30ML LL BNS WAS DAMAGED AND HAD IMPROPER LABELING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SYRINGE MISSING NUMBERS & DAMAGED TIP."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1244462 SYRINGE 30ML LL BNS PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 0100616 00382903056187

    Patients

    Seq Age Sex Outcome Treatment
    1