BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1.0ML 30GA 8MM 7BAG 420CAS JP

    MDR report key: 10227310 · Received July 2, 2020

    Report

    Report Number
    1920898-2020-00786
    Event Type
    Malfunction
    Date Received
    July 2, 2020
    Date of Event
    June 15, 2020
    Report Date
    July 22, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6. INVESTIGATION: CUSTOMER RETURNED THREE (3) 30GX8MM, 1ML BD INSULIN SYRINGES FROM AN OPEN POLYBAG FROM LOT 8162853. CONSUMER REPORTED A BENT BARREL WAS FOUND. ALL THREE SYRINGES WERE EXAMINED, AND IT WAS OBSERVED THAT ONE OUT OF THE THREE SYRINGES EXHIBITED A BOWED BARREL. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 8162853. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE SEVEN (7) NOTIFICATIONS [200769369, 200768467, 200768465, 200767901, 200768483, 200768576, 200768636] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. PROCESS SUMMARY: THE AUTOMATIC SYRINGE ASSEMBLY MACHINE FEEDS 1ML SYRINGE COMPONENTS (BARREL, STOPPER, PLUNGER, AND CAP) AND ASSEMBLES THESE COMPONENTS. THIS MACHINE CONSISTS OF A BARREL-CLEANING DIAL, LUBRICATION DIAL, ONE PLUNGER/STOPPER ASSEMBLY DIAL AND ONE SYRINGE ASSEMBLY DIAL AND VARIOUS INSPECTION AND TRANSFER DIALS. THERE WERE NO QUALITY NOTIFICATIONS OR MAINTENANCE DISPATCHES THAT PERTAINED TO THIS DEFECT DURING THE PRODUCTION OF THIS BATCH. A ROOT CAUSE CANNOT BE DETERMINED. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 SYRINGES 1.0ML 30GA 8MM 7BAG 420CAS JP WERE FOUND WITH BENT BARRELS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: "A BENT BARREL WAS FOUND."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 3 SYRINGES 1.0ML 30GA 8MM 7BAG 420CAS JP WERE FOUND WITH BENT BARRELS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "A BENT BARREL WAS FOUND."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686505 SYRINGE 1.0ML 30GA 8MM 7BAG 420CAS JP PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 8162853

    Patients

    Seq Age Sex Outcome Treatment
    1 Other