BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    20 ML BD LUER-LOK SYRINGE

    MDR report key: 10915198 · Received November 27, 2020

    Report

    Report Number
    1911916-2020-01072
    Event Type
    Malfunction
    Date Received
    November 27, 2020
    Date of Event
    October 23, 2020
    Report Date
    November 13, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 301031 AND LOT NUMBER 0100584. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES THAT COULD HAVE CONTRIBUTED TO THESE REPORTED DEFECTS. TO AID IN THE INVESTIGATION, TEN PHYSICAL SAMPLES AND SIX PHOTOS WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THE TEN SAMPLES CAME IN A PLASTIC BAG. A VISUAL INSPECTION WAS PERFORMED. FIVE SAMPLES HAVE EMBEDDED DEGRADED RESIN AND NO OTHER DEFECTS WERE OBSERVED. THE SIX PHOTOS SHOW 50 ML SYRINGE BARRELS WITH EMBEDDED DEGRADED RESIN. IT COULD BE POSSIBLE FOR THIS DEFECT TO OCCUR DURING THE SYRINGE MOLDING PROCESS. DEGRADED RESIN INHERENTLY BUILDS UP, CAN BREAK LOOSE AND BE MOLDED INTO COMPONENTS. BASED ON THE INVESTIGATION WITH THE SAMPLE ANALYSIS THE FOREIGN MATTER DEFECT REPORTED BY THE CUSTOMER IS CONFIRMED. THERE ARE QUALITY CONTROLS CURRENTLY IN PLACE TO DETECT THIS TYPE OF DEFECT DURING THE PRODUCTION PROCESS. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. 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. INVESTIGATION CONCLUSION: BASED ON THE INVESTIGATION AND WITH THE SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. WE WILL CONTINUE MONITORING THE COMPLAINT TREND FOR THE PRODUCT AND SYMPTOM. PROBABLE ROOT CAUSE. SYRINGE MOLDING PROCESS. THE EMBEDDED DEGRADED RESIN IN THE BARREL CAN OCCUR AT THE STARTUP OF AN INJECTION MOLD/PRESS OR INTERMITTENTLY DURING THE INJECTION MOLDING PROCESS. DEGRADED RESIN INHERENTLY BUILDS UP IN THE HOT-RUNNER SYSTEM OF THE TOOLING MOLD AND PRESS. THE DEGRADED RESIN CAN BREAK LOOSE AND BE MOLDED INTO COMPONENTS. IT IS RECOMMENDED THAT HYPODERMIC MARKETING ASKS THE CUSTOMER TO SEND THE 485 UNITS REPORTED AS DEFECTIVE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 124 20 ML BD LUER-LOK¿ SYRINGES EXPERIENCED DEVICE DAMAGE/DEFORMATION WHILE STILL CONSIDERED OPERABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 301031 BATCH NO.: 0100584. THE PURPOSE OF THIS EMAIL IS TO LET YOU KNOW THE SYRINGES DEFECTS FOR THIS PAST MONTH, (B)(6) 2020. CERTIFICATE OF DESTRUCTION AND THE FOLLOWING INFORMATION FOR EACH CERTIFICATE: DATE: (B)(6) 2020 PART NUMBER: 301031, LOT NUMBER: 0100584, BLACK DOTS: (B)(4) PIECES, DAMAGED/BROKEN: (B)(4) PIECES, TOTAL: (B)(4) PIECES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1378982 20 ML BD LUER-LOK SYRINGE PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 0100584

    Patients

    Seq Age Sex Outcome Treatment
    1