BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 60ML LL TIP 1ML 2 OZ IN 1/4 OZ

    MDR report key: 9800494 · Received March 6, 2020

    Report

    Report Number
    1911916-2020-00220
    Event Type
    Malfunction
    Date Received
    March 6, 2020
    Date of Event
    February 24, 2020
    Report Date
    February 27, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    30382903096535
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9275467, MEDICAL DEVICE EXPIRATION DATE: 2024-09-30, DEVICE MANUFACTURE DATE: 2019-10-02. MEDICAL DEVICE LOT #: 9240162, MEDICAL DEVICE EXPIRATION DATE: 2024-08-31, DEVICE MANUFACTURE DATE: 2019-08-28. INVESTIGATION SUMMARY: 93 SAMPLES WERE RECEIVED. NO PHOTOS WERE PROVIDED. THEY CAME IN THE SEALED PACKAGING BLISTER. VISUAL INSPECTION WAS PERFORMED. THEY ARE DAMAGED AT THE 35ML MARK AREA. IT COULD HAVE HAPPENED A JAM DURING THE ASSEMBLY PROCESS IN ONE OF THE CONVEYORS INDUCING THIS BARREL DAMAGE AND WAS NOT DETECTED IN THE NEXT PROCESSES. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED WITH ZERO DEFECTS FOUND. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES. INVESTIGATION CONCLUSION: THIS IS THE 1ST COMPLAINT FOR LOT #S 9275467, 9240162 FOR THIS TYPE OF DEFECT OR SYMPTOM. THERE WAS NO DOCUMENTATION FOR THIS TYPE OF DEFECT DURING THE ENTIRE PRODUCTION RUN OF THESE BATCH #S. ROOT CAUSE DESCRIPTION: SYRINGE ASSEMBLY PROCESS. IT COULD HAVE HAPPENED A JAM DURING THE ASSEMBLY PROCESS IN ONE OF THE CONVEYORS INDUCING THIS BARREL DAMAGE AND WAS NOT DETECTED IN THE NEXT PROCESSES. RATIONALE: CAPA NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 91 SYRINGES 60ML LL TIP 1ML 2 OZ IN 1/4 OZ EXPERIENCED A FAILURE OF PRODUCT TO CONTAIN BLOOD/MEDICATION AND DEVICE DAMAGE/DEFORMATION -DEVICE STILL OPERABLE. THE PRODUCT DEFECTS WERE NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 309653 BATCH NO.: 9275467 , 9240162. WE HAVE FOUND MANY 50ML SYRINGES ITEM # 309653 WITH DENTS / CRACKS IN THE SIDE OF THE BARREL. SOME OF THEM ARE SEVERE ENOUGH TO PREVENT THE PLUNGER FROM BEING DRAWN BACK. WE HAVE 87 FROM LOT # 9275467 AND 4 FROM LOT # 9240162 SO FAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259959 SYRINGE 60ML LL TIP 1ML 2 OZ IN 1/4 OZ PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 309653 SEE H.10 30382903096535

    Patients

    Seq Age Sex Outcome Treatment
    1 Other