BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ TIP SYRINGE

    MDR report key: 15419312 · Received September 14, 2022

    Report

    Report Number
    1911916-2022-00495
    Event Type
    Malfunction
    Date Received
    September 14, 2022
    Date of Event
    August 16, 2022
    Report Date
    August 26, 2022
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    00382903028306
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2152006. MEDICAL DEVICE EXPIRATION DATE: 31-MAY-2027. DEVICE MANUFACTURE DATE: (B)(6) 2022. MEDICAL DEVICE LOT #: 1307344. MEDICAL DEVICE EXPIRATION DATE: 31-OCT-2026. DEVICE MANUFACTURE DATE: (B)(6) 2021. IT WAS REPORTED THERE WAS SOME FORM OF PARTICULATE MATTER FOUND IN MANY OF THE SYRINGES. TO AID IN THE INVESTIGATION, SEVEN SAMPLES IN SEALED PACKAGING BLISTERS AND FIVE PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED AND THE SYRINGES HAVE BLACK SPECKS OF EMBEDDED DEGRADED RESIN. 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. THE FIVE PHOTOS PROVIDED SHOW THE SAMPLES RECEIVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 302830, LOT NUMBERS 2152006 AND 1307344. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THESE LOTS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. VERIFICATION OF THE MOLDING PROCESS WAS PERFORMED. THE SETTINGS WERE CORRECT AND THE FLOW OF PRODUCT WAS GOOD. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THESE LOTS. 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 1 BD LUER-LOK¿ TIP SYRINGE EACH FROM LOTS 2152006 AND 1307344 HAD FOREIGN MATTER IN THEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SURGERY CENTER HAS IDENTIFIED A CONTAMINATION ISSUE WITH 20CC BD SYRINGES CONTAINING THE LOT# 215006. THERE WAS SOME FORM OF PARTICULATE MATTER FOUND IN MANY OF THE SYRINGES¿¿ STERILE PACKAGING AS WELL AS WITHIN THE SYRINGES THEMSELVES. IN SOME IT CAN BE HARD TO SEE, IN OTHERS, IT¿¿S VERY OBVIOUS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2496743 BD LUER-LOK¿ TIP SYRINGE PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL SEE H10 00382903028306

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown