BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE

    MDR report key: 8166531 · Received December 14, 2018

    Report

    Report Number
    1920898-2018-00936
    Event Type
    Malfunction
    Date Received
    December 14, 2018
    Date of Event
    November 27, 2018
    Report Date
    February 4, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908466035
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER RETURNED (10) 1/2CC, 12.7MM, 30G SYRINGES IN A SEALED POLY BAG FROM CAT # 328466, LOT # 8022769 AND (10) 1/2CC, 6MM, 31G SYRINGES IN A SEALED POLY BAG FROM LOT # 8022764. CUSTOMER STATES THAT SHE RECEIVED A BOX OF SYRINGES IN WHICH THERE WAS ONE BAG THAT WAS WRITTEN IN SPANISH AND THE ITEM NUMBER WAS DIFFERENT FROM THE OTHER 9 PACKAGES. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 8022769. 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. 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. AS PER MANUFACTURING, PROBABLE ROOT CAUSE: THE ONE INCORRECT BAG FOUND IN THE CARTON WITH (B)(4) CORRECT BAGS WAS CAUSED MOST LIKELY FROM AN INCOMPLETE CHANGEOVER. A BAG OF SYRINGES FROM BATCH 8022764 WAS NOT CLEARED FROM THE LINE AND WAS INADVERTENTLY REINTRODUCED DURING THE PRODUCTION OF BATCH 8022769. A SITUATION ANALYSIS HAS BEEN WRITTEN FOR THIS ISSUE- (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SHELF CARTON OF BD INSULIN SYRINGES WITH THE BD ULTRA-FINE¿ NEEDLES CONTAINED MIXED PRODUCTS.

    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 THE SHELF CARTON OF BD INSULIN SYRINGES WITH THE BD ULTRA-FINE¿ NEEDLES CONTAINED MIXED PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1003157 BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 8022769 00382908466035

    Patients

    Seq Age Sex Outcome Treatment
    1 Other