BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK SYRINGE

    MDR report key: 12255019 · Received July 30, 2021

    Report

    Report Number
    1911916-2021-00765
    Event Type
    Malfunction
    Date Received
    July 30, 2021
    Date of Event
    July 1, 2021
    Report Date
    July 19, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: IT WAS REPORTED THERE WAS ISSUES WITH BLACK SPOTS. TO AID IN THE INVESTIGATION, FIVE SAMPLES WITH NO PACKAGING BLISTERS AND THREE PHOTOS WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED. TWO SAMPLES HAVE EMBEDDED DEGRADED RESIN AND THE OTHER THREE SAMPLES HAVE A SCALE MARKING ISSUE. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THE THREE PHOTOS PROVIDED SHOW THE SAMPLES RECEIVED. THE EMBEDDED DEGRADED RESIN IN THE COMPONENT TYPICALLY OCCURS AT THE STARTUP OR INTERMITTENTLY DURING THE INJECTION MOLDING PROCESS. THE DEGRADED RESIN CAN BREAK LOOSE AND BE MOLDED INTO COMPONENTS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 301033, LOT NUMBER 9232577. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECTS. VERIFICATION OF THE SETTINGS AND ALIGNMENT OF THE PRINTING PROCESS WAS PERFORMED FINDING EVERYTHING ACCEPTABLE. FREQUENCY OF INSPECTIONS WAS INCREASED TO MITIGATE THE RISK OF EMBEDDED DEGRADED RESIN ESCAPES. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOMS REPORTED BY THE CUSTOMER ARE 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 THAT 2 BD LUER-LOK¿ SYRINGES HAD BLACK FOREIGN MATTER ON THEIR WING AND PLUNGER RESPECTIVELY. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "1 SYRINGE WITH BLACK SPOT ON THE WING 1 SYRINGE WITH BLACK DOTS/STAINS ALL OVER THE PLUNGER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1148249 BD LUER-LOK SYRINGE PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 9232577

    Patients

    Seq Age Sex Outcome Treatment
    1