BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8366040 · Received February 25, 2019

    Report

    Report Number
    1920898-2019-00196
    Event Type
    Malfunction
    Date Received
    February 25, 2019
    Date of Event
    February 1, 2019
    Report Date
    March 4, 2019
    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

    INVESTIGATION SUMMARY: CUSTOMER RETURNED (1) 1/2CC, 12.7MM, 29G SYRINGE IN AN OPEN POLY BAG FROM LOT # 8072656. CUSTOMER STATES THAT THE NEEDLE PIERCED THROUGH THE SHIELD AND IS BENT. THE RETURNED SYRINGE WAS EXAMINED AND EXHIBITED THE NEEDLE BENT BETWEEN THE HUB AND SHIELD, EXPOSING THE CANNULA POINT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 8072656. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BASED ON THE SAMPLES AND/OR PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (EXPOSED CANNULA). 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. BASED ON THE ABOVE, NO CAPA IS REQUIRED AT THIS TIME. POSSIBLE ROOT CAUSES: MANUFACTURING PROCESS: NEEDLE WAS BENT DURING THE SHIELDING PROCESS AND WAS NOT DETECTED AT THE POINT INSPECT MACHINE, WHERE AN ELECTRICAL CURRENT IS PASSED OVER THE SHIELD AND EJECTS PARTS WHERE AN ARC IS DETECTED. ADDITIONALLY, NEEDLE THROUGH SHIELD WOULD HAVE HAD TO PASS THROUGH UNDETECTED BY THE CAMERA SYSTEM UTILIZED ON THE PRODUCTION LINE. BOTH SYSTEMS ARE CHALLENGED AT REGULAR INTERVALS DURING PRODUCTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SYRINGE 0.5ML 29GA 1/2IN 7BAG 420CAS JP PIERCED THROUGH THE SHIELD.

    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 SYRINGE 0.5ML 29GA 1/2IN 7BAG 420CAS JP PIERCED THROUGH THE SHIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161906 SYRINGE 0.5ML 29GA 1/2IN 7BAG 420CAS JP PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 8072656

    Patients

    Seq Age Sex Outcome Treatment
    1 Other