BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN¿ SYRINGE

    MDR report key: 7562057 · Received June 1, 2018

    Report

    Report Number
    1920898-2018-00366
    Event Type
    Malfunction
    Date Received
    June 1, 2018
    Date of Event
    May 8, 2018
    Report Date
    June 28, 2018
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00681131138376
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: CUSTOMER RETURNED (1) LOOSE 1/2CC, 6MM SYRINGE WITH PART OF THE SHELF CARTON FROM LOT # 7093620. CUSTOMER STATES THAT THE RUBBER STOPPER IS MISSING. THE RETURNED SYRINGE WAS EXAMINED AND EXHIBITED A MISSING STOPPER. NO DAMAGE TO THE PLUNGER ROD WAS OBSERVED. ON 05JUN2018, HOLDREGE RECEIVED ONE (1) LOOSE 0.5ML, 6MM SYRINGE WITH PARTIAL SHELF CARTON FROM BATCH# 7093620. ALL SAMPLES WERE DECONTAMINATED PER HSTR-17 PRIOR TO BEING EVALUATED. UPON EVALUATION BY QE AH, SIMILAR FINDINGS TO THOSE DOCUMENTED DURING INITIAL INVESTIGATION PERFORMED AT BD FRANKLIN LAKES WERE NOTED. PROBABLE ROOT CAUSE IS A JAM DURING ASSEMBLY OF THE STOPPER ONTO THE PLUNGER ROD. WHEN THIS OCCURS, A PLUNGER ROD MAY PASS THROUGH THE LINE WITHOUT A STOPPER ATTACHED, THEN ON TO FINISHED PRODUCT. CONTINUOUS IMPROVEMENT PROJECTS WITHIN THE PLANT ARE REVIEWING THIS TYPE OF DEFECT FOR OPPORTUNITIES FOR IMPROVEMENT OF THE PROCESSES AND PRODUCTION LINES. NO ADDITIONAL ACTIONS AT THIS TIME. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 7093620. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200692727] NOTED THAT DID NOT PERTAIN 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 INVESTIGATION CONCLUSION: PROBABLE ROOT CAUSE FOR MISSING STOPPER: AT THE STOPPER ASSEMBLY ON THE METRO MACHINE AS THE DIAL FOR THE PLUNGER COMES AROUND FOR THE MARRIAGE OF THE STOPPER TO PLUNGER, A PLUNGER COULD GET HUNG UP IN THE DIAL AND NOT ALLOW THE STOPPER TO ASSEMBLE TO THE PLUNGER.

    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 BD INSULIN¿ SYRINGE WAS MISSING THE STOPPER BEFORE USE. THERE WAS NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404183 BD INSULIN¿ SYRINGE INSULIN SYRINGE FMF BD MEDICAL - DIABETES CARE 7093620 00681131138376

    Patients

    Seq Age Sex Outcome Treatment
    1 Other