BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    50 ML BD LUER-LOK¿ SYRINGE STERILE, SINGLE USE

    MDR report key: 15678774 · Received October 27, 2022

    Report

    Report Number
    1911916-2022-00590
    Event Type
    Malfunction
    Date Received
    October 27, 2022
    Date of Event
    October 3, 2022
    Report Date
    November 14, 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
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL? YES. D10: RETURNED TO MANUFACTURER ON: 19-OCT-2022. H6: INVESTIGATION SUMMARY: IT WAS REPORTED THE SYRINGE APPEARS TO HAVE SOMETHING GROWING IN IT, POSSIBLY MOLD. TO AID IN THE INVESTIGATION, FOUR SAMPLES WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. ONE SAMPLE CAME IN AN OPENED PACKAGING BLISTER AND THE OTHER THREE SAMPLES IN SEALED PACKAGING BLISTERS. A VISUAL INSPECTION WAS PERFORMED. THE THREE SAMPLES IN SEALED PACKAGING BLISTERS HAD NO DEFECTS OR IMPERFECTIONS OBSERVED. THE SAMPLE RECEIVED IN AN OPEN PACKAGING BLISTER HAS EMBEDDED DEGRADED RESIN IN THE PLUNGER ROD. THE SAMPLE WAS SENT TO A LABORATORY FOR ANALYSIS. THE ANALYSIS REPORT CONFIRMED THAT THERE WAS NO MOLD AND THAT THE FOREIGN MATTER OBSERVED WAS EMBEDDED DEGRADED RESIN. 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 2210414. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED.

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING 50 ML BD LUER-LOK¿ SYRINGE STERILE, SINGLE USE FOREIGN MATTER WAS FOUND. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE SYRINGE APPEAR TO HAVE SOMETHING GROWING IN IT. POSSIBLY MOLD. THE DEFECTIVE PRODUCT WAS NOTICED PRIOR TO BEING USED ON A PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING 50 ML BD LUER-LOK¿ SYRINGE STERILE, SINGLE USE FOREIGN MATTER WAS FOUND. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE SYRINGE APPEAR TO HAVE SOMETHING GROWING IN IT. POSSIBLY MOLD. THE DEFECTIVE PRODUCT WAS NOTICED PRIOR TO BEING USED ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2945860 50 ML BD LUER-LOK¿ SYRINGE STERILE, SINGLE USE PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 2210414 00382903096534

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown