BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.5ML 29GA 1/2IN 7BAG 420CAS JP

    MDR report key: 9644370 · Received January 29, 2020

    Report

    Report Number
    1920898-2020-00053
    Event Type
    Malfunction
    Date Received
    January 29, 2020
    Date of Event
    January 7, 2020
    Report Date
    March 26, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER RETURNED TEN (10) 29GX12.7MM, 0.5ML BD INSULIN SYRINGES FROM OPENED POLYBAGS FROM LOT 9042860. CONSUMER REPORTED WHEN REMOVING THE SHIELD SOME CANNULAS BENT AND OTHER BROKE. ALL TEN RETURNED SYRINGES WERE EXAMINED AND IT WAS OBSERVED THAT NINE OF THE SYRINGES EXHIBITED BROKEN BARREL TIPS. ONE SYRINGE DID NOT EXHIBIT A BROKEN BARREL TIP, NOR A BENT OR BROKEN CANNULA; NO EVIDENCE OF MANUFACTURING DEFECT WAS OBSERVED ON THIS SAMPLE. THE BROKEN BARREL TIP WOULD BE THE REASON WHY THE CUSTOMER WOULD THINK THE CANNULA WAS BROKEN (AS REPORTED). A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9042860. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (BARREL TIP BROKEN). UNCONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (CANNULA BENT). PROCESS SUMMARY: THE POLYBAG IS FORMED FROM A ROLL OF WEB THAT IS MANIPULATED SO THAT IT WRAPS AROUND A METAL TUBE AND THE SIDES OF THE WEB OVERLAP ALONG THE FRONT OF THE TUBE TO BE SEALED. THE SEALING JAW FORMS THE POLYBAG BOTTOM, AS WELL AS THE TOP OF THE PREVIOUS BAG. THE SYRINGES DROP BY GRAVITY THROUGH THE TUBE COMING TO REST ON TOP OF THE JAW. WHEN THE POLYBAG IS RELEASED, IT IS DROPPED BY GRAVITY ONTO A CHUTE. IF THE PRODUCT IS GOOD THE CHUTE TRANSFERS THE BAG TO THE INFEED CONVEYOR. THE EQUIPMENT ERECTS CHIPBOARD CARTON AND ASSOCIATES HAND LOAD THE APPROPRIATE NUMBER OF BAGS INTO THE CARTONS. THE CARTONS ARE CLOSED AND PASS OVER A WEIGH SCALE TO ENSURE THE CORRECT NUMBER OF BAGS. THE CASE PACK EQUIPMENT PUTS 5 CARTONS INTO A CASE WHICH IS THEN PASSED OVER A WEIGHT SCALE TO ENSURE THE CORRECT NUMBER OF CARTONS ARE PRESENT. DHR, L2L DISPATCHES, AND LOGBOOK ENTRIES WERE LOOKED AT, NOTHING PERTAINING TO THIS DEFECT WAS FOUND. ROOT CAUSE FOR THIS DEFECT CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BENT CANNULA WAS FOUND BEFORE USE WITH A SYRINGE 0.5ML 29GA 1/2IN 7BAG 420CAS JP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. "WHEN REMOVING THE SHIELD, SOME CANNULAS BENT AND OTHER BROKE." 3 OCCURRENCES WERE REPORTED.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BENT CANNULA WAS FOUND BEFORE USE WITH A SYRINGE 0.5ML 29GA 1/2IN 7BAG 420CAS JP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "WHEN REMOVING THE SHIELD, SOME CANNULAS BENT AND OTHER BROKE." 3 OCCURRENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108438 SYRINGE 0.5ML 29GA 1/2IN 7BAG 420CAS JP SYRINGE FMF BD MEDICAL - DIABETES CARE 9042860

    Patients

    Seq Age Sex Outcome Treatment
    1 Other