BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 30ML LL BNS

    MDR report key: 11233881 · Received January 26, 2021

    Report

    Report Number
    1911916-2021-00057
    Event Type
    Malfunction
    Date Received
    January 26, 2021
    Date of Event
    December 7, 2020
    Report Date
    January 21, 2021
    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 301033 AND LOT NUMBER 0115982. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED DEFECT. TO AID IN THE INVESTIGATION, TEN PHYSICAL SAMPLES AND THREE PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE SAMPLES CAME IN A PLASTIC BAG. A VISUAL INSPECTION WAS PERFORMED AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. IT COULD BE POSSIBLE THAT THE CUSTOMER PICKED GOOD PRODUCT TO RETURN INSTEAD OF THE SUSPECTED DEFECTIVE ONE. IN THE PHOTOS PROVIDED, TWO SHOW SYRINGE BARRELS WITH EMBEDDED DEGRADED RESIN AND THE THIRD PHOTO SHOWS A PLUNGER ROD DAMAGED. IT COULD BE POSSIBLE FOR THE EMBEDDED DEGRADED RESIN TO OCCUR DURING THE SYRINGE MOLDING PROCESS. DEGRADED RESIN INHERENTLY BUILDS UP, CAN BREAK LOOSE AND BE MOLDED INTO COMPONENTS. FOR THE DAMAGED PLUNGER ROD, A JAM MAY HAVE OCCURRED AT THE PLUNGER ROD-STOPPER ASSEMBLY INDUCING THE DEFECT. BASED ON THE INVESTIGATION WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM 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 PHOTO 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. FOR THE PLUNGER ROD DAMAGED A JAM MAY HAVE OCCURRED AT THE PLUNGER ROD-STOPPER ASSEMBLY PROCESS INDUCING THE DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 30ML LL BNS EXPERIENCED 364 INSTANCES OF FOREIGN MATTER CONTAMINATION AND 46 INSTANCES OF BROKEN/DAMAGED PLUNGER RODS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 301033, BATCH NO.: 0115982. BLACK DOTS: 364 PIECES. DAMAGED/BROKEN: 46 PIECES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130729 SYRINGE 30ML LL BNS PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 0115982

    Patients

    Seq Age Sex Outcome Treatment
    1