BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿

    MDR report key: 14002103 · Received April 4, 2022

    Report

    Report Number
    1911916-2022-00182
    Event Type
    Malfunction
    Date Received
    April 4, 2022
    Date of Event
    March 16, 2022
    Report Date
    March 22, 2022
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    30382903096535
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THERE WAS FOREIGN MATTER ON THE PRODUCT. TO AID IN THE INVESTIGATION, ONE SAMPLE IN AN OPENED PACKAGING BLISTER WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED AND THE PLUNGER ROD HAS TWO RIBS WITH EMBEDDED DEGRADED RESIN. IT WAS NOT POSSIBLE TO REMOVE THE RESIN WITH A PRE-SATURATED 70/30 IPA/DI WATER WIPE. 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 2033192. 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 THE MOLDING PROCESS WAS PERFORMED. THE SETTINGS WERE CORRECT AND THE FLOW OF PRODUCT WAS GOOD. THERE WAS NO EMBEDDED DEGRADED RESIN OR ANY OTHER FOREIGN MATTER WAS OBSERVED. 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 THE BD LUER-LOK¿ HAD FOREIGN MATTER/MOLD ON PLUNGER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CLIENT: "CUSTOMER STATED THAT THERE WAS A BLACK, MOLD LIKE MATTER ON PLUNGER. NOT USED ON A PATIENT. NO ADVERSE EVENTS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603482 BD LUER-LOK¿ PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 2033192 30382903096535

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown