BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ TIP SYRINGE

    MDR report key: 15505693 · Received September 29, 2022

    Report

    Report Number
    1911916-2022-00540
    Event Type
    Malfunction
    Date Received
    September 29, 2022
    Date of Event
    September 7, 2022
    Report Date
    September 12, 2022
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    00382903096534
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: IT WAS REPORTED THERE WAS DARK MATTER IN A 50ML LUER LOK SYRINGE. TO AID IN THE INVESTIGATION, ONE SAMPLE WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THE SAMPLE WAS CONTAMINATED WITH AN UNKNOWN DRUG. A VISUAL INSPECTION WAS PERFORMED USING A 10X MAGNIFIER LENS AND THE SYRINGE BARREL HAS A BLACK SPECK OF EMBEDDED DEGRADED RESIN AT THE BOTTOM. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. 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 309653, LOT NUMBER 2153745. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THE FREQUENCY OF INSPECTIONS WERE INCREASED TO MITIGATE THE ESCAPE OF THIS DEFECT. 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 · 0

    IT WAS REPORTED THAT DARK FOREIGN MATTER WAS FOUND IN THE BD LUER-LOK¿ TIP SYRINGE WHILE COMPOUNDING MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ONE OF OUR TECHNICIANS WAS COMPOUNDING WHEN THEY FOUND A DARK MATTER IN A STERILE 50ML LUER LOCK SYRINGE. LOT #2153745, EXPIRY 2027-05-31. THIS WAS IDENTIFIED AND NOT DISPENSED TO ANY PATIENTS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1700183 BD LUER-LOK¿ TIP SYRINGE PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 2153745 00382903096534

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown