BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE INSULIN SYRINGES

    MDR report key: 8265498 · Received January 21, 2019

    Report

    Report Number
    1920898-2019-00002
    Event Type
    Malfunction
    Date Received
    January 21, 2019
    Date of Event
    January 4, 2019
    Report Date
    January 24, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903282906
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: CUSTOMER RETURNED (1) 1/2CC, 8MM, 31G SYRINGE IN AN OPEN POLY BAG WITH PART OF THE SHELF CARTON FROM LOT # 8162537. CUSTOMER STATES THAT THE THUMB PRESS AND PLUNGER CAP ARE BROKEN ON ONE SYRINGE AND IT APPEARS THAT THE END OF THE SYRINGE WAS STUCK IN THE SEAL OF THE BAG. THE RETURNED SYRINGE WAS EXAMINED AND EXHIBITED A BROKEN THUMB PRESS AND CRUSHED PLUNGER CAP WITH THE PLUNGER CAP CAUGHT IN THE SEAL OF THE POLY BAG. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 8162537. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (BROKEN THUMB PRESS, CRUSHED PLUNGER CAP CAUGHT IN SEAL OF POLY BAG). 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 CAUSE: THE SYRINGE WAS CAUGHT IN THE SEALING BARS OF THE PACKAGING MACHINE, CRUSHING THE CAP AND BREAKING THE PLUNGER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A THUMB PRESS AND A PLUNGER CAP OF A BD¿ ULTRA-FINE INSULIN SYRINGES WERE BROKEN.

    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 THUMB PRESS AND A PLUNGER CAP OF A BD¿ ULTRA-FINE INSULIN SYRINGES WERE BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58582 BD ULTRA-FINE INSULIN SYRINGES INSULIN SYRINGE/NEEDLE FMF BD MEDICAL - DIABETES CARE 8162537 00382903282906

    Patients

    Seq Age Sex Outcome Treatment
    1 Other