BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ INSULIN SYRINGE

    MDR report key: 7860712 · Received September 10, 2018

    Report

    Report Number
    1920898-2018-00698
    Event Type
    Malfunction
    Date Received
    September 10, 2018
    Date of Event
    July 31, 2018
    Report Date
    September 20, 2018
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903249183
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER RETURNED PHOTOS OF 1CC, 6MM, 31G SYRINGES IN A POLY BAG FROM LOT # 7240675. CUSTOMER STATES THAT THERE WAS A SHORT PUNCTURE ACCIDENT WITH A SYRINGE THAT CAME IN ITS PACKAGING WITHOUT A NEEDLE SHIELD. THE ATTACHED PHOTOS WERE EXAMINED AND EXHIBITED ONE SYRINGE IN THE POLY BAG WITH THE SHIELD OFF AND SEPARATED IN THE BAG WITH THE CANNULA EXPOSED. SINCE THE CANNULA WAS EXPOSED, A NEEDLE STICK COULD OCCUR. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 7240675. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE THREE (3) NOTIFICATIONS [200713211, 200712839, 200713093] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. SEVERITY: S_2__; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR NEEDLE STICK (BEFORE USE) AND MISSING NEEDLE SHIELD ON LOT # 7240675. BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE OF THE BD ULTRA-FINE¿ INSULIN SYRINGES WAS MISSING THE NEEDLE SHIELD IN THE PACKAGE, AND THE DEVICE EXPERIENCED A STERILE BREACH. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    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 BEFORE USE OF THE BD ULTRA-FINE¿ INSULIN SYRINGES WAS MISSING THE NEEDLE SHIELD IN THE PACKAGE, AND THE DEVICE EXPERIENCED A STERILE BREACH. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703481 BD ULTRA-FINE¿ INSULIN SYRINGE INSULIN SYRINGE FMF BD MEDICAL - DIABETES CARE 7240675 00382903249183

    Patients

    Seq Age Sex Outcome Treatment
    1 Other