BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE

    MDR report key: 7286262 · Received February 21, 2018

    Report

    Report Number
    1920898-2018-00048
    Event Type
    Malfunction
    Date Received
    February 21, 2018
    Date of Event
    January 29, 2018
    Report Date
    March 12, 2018
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903249107
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 0

    OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 4TH RELATED COMPLAINT REPORTED FOR THE DEFECT/CONDITION ON LOT NUMBER 6242615. TWO INVESTIGATIONS WERE PERFORMED. FIRST INVESTIGATION SUMMARY: CUSTOMER RETURNED (2) LOOSE 3/10CC SYRINGES. CUSTOMER STATES THAT THE SYRINGE HUB IS SEPARATED FROM THE BARREL. BOTH SYRINGES WERE RETURNED WITH THE HUB-NEEDLE/SHIELD ASSEMBLY SEPARATED FROM THE BARREL. NO DAMAGE TO THE BARRELS WAS OBSERVED. (B)(4) HAS BEEN OPENED TO ADDRESS THIS ISSUE. THEREFORE NO DEVICE HISTORY REVIEW IS NECESSARY. SAMPLES WERE FORWARDED TO MANUFACTURING (HOLDREGE) ON 16FEB2018 FOR FURTHER REVIEW. ON 23FEB2018, HOLDREGE RECEIVED TWO (2) LOOSE 0.3ML SYRINGES FROM REPORTED BATCH# 6242615. ALL SAMPLES WERE DECONTAMINATED PER HSTR-17 PRIOR TO BEING EVALUATED. SECOND INVESTIGATION SUMMARY: UPON EVALUATION BY QE AH, SIMILAR FINDINGS TO THOSE DOCUMENTED DURING INITIAL INVESTIGATION PERFORMED AT BD FRANKLIN LAKES WERE NOTED. NO ADDITIONAL INFORMATION WAS NOTED DURING THIS EVALUATION. (B)(4) WAS INITIATED BY THE HOLDREGE PLANT TO ADDRESS HUB SEPARATES AND THEIR ASSOCIATED ROOT CAUSE(S). BATCH# 6242615 WAS MANUFACTURED PRIOR TO IMPLEMENTATION OF CORRECTIVE/PREVENTIVE ACTIONS ASSOCIATED WITH THIS CAPA. BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. POSSIBLE ROOT CAUSES FOR HUB SEPARATES ISSUE INCLUDE: BROKEN PLUNGER LODGED IN BETWEEN BARREL AND SHIELD CARRIERS MAY CAUSE INCOMPLETE SHIELD ASSEMBLIES. SYSTEMS WITH PLUNGER SCREW IN FEED HAVE A GREATER PROPENSITY FOR CREATING BROKEN PLUNGERS VERSUS MACHINES WITH DIAL IN FEEDS. A MISALIGNED LASER SENSOR (RAISED SHIELD) FROM ITS DESIGNATED DETECTING POSITION MAY RESULT IN SENDING DEFECTIVE PARTS WITH GATE FLASH AND/OR RAISED NEEDLE ASSEMBLIES TO PACKAGING AS GOOD PRODUCT. HUB CORE DAMAGE (EITHER FROM SEATING ON RACKS OR DURING ASSEMBLY ONTO BARREL), ADHESIVE RUN-OVER CAUSING EXCESSIVE FORCE REQUIRED TO REMOVE SHIELD, DISASSEMBLING HUB FROM THE SYRINGE CAPA 97451 HAS BEEN OPENED TO ADDRESS THIS ISSUE. 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.

    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 WHILE PREPARING AN INJECTION, THE BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE SEPARATED. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130941 BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE INSULIN SYRINGE FMF BD MEDICAL - DIABETES CARE 6242615 00382903249107

    Patients

    Seq Age Sex Outcome Treatment
    1 Other