BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE

    MDR report key: 7309456 · Received March 2, 2018

    Report

    Report Number
    1920898-2018-00093
    Event Type
    Malfunction
    Date Received
    March 2, 2018
    Date of Event
    February 7, 2018
    Report Date
    March 27, 2018
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER RETURNED ONE 3/10CC, 12.7MM, 29G SYRINGE IN AN OPEN POLY BAG FROM LOT # 7121520. CUSTOMER STATES THAT THEY COULDN'T PRESS THE PLUNGER UNTIL THE END. THE RETURNED SYRINGE WAS TESTED AND THE SYRINGE WAS NOT ABLE TO DRAW PROPERLY. THE SAMPLE WAS THEN WIRED AND THE WIRE WAS NOT ABLE TO PASS THROUGH THE CANNULA. THIS IS INDICATIVE OF AN ADHESIVE CLOG IN THE CANNULA. AS PER MANUFACTURING, A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH #7121520. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE NOTIFICATION NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. HOLDREGE RECEIVED ONE 0.3ML, 12.7MM, 29G SYRINGE IN OPENED POLYBAG FROM BATCH# 7121520. 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. THE PRECISE CAUSE OF THE CLOG IS UNABLE TO BE DETERMINED, HOWEVER, AS THE MATERIAL IS UNABLE TO BE VISUALIZED OR TESTED. PROBABLE ROOT CAUSE IS LIKELY TO BE ADHESIVE FROM THE CANNULATION PROCESS ON THE NEEDLE LINES MADE IT'S WAY INTO THE INTERIOR OF THE CANNULA. INVESTIGATION CONCLUSION: BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (ADHESIVE CLOG). POSSIBLE ROOT CAUSE: THIS WAS POSSIBLY A TRANSFER PROBLEM AT THE CANNULATOR, WHEREBY A CANNULA FALLS LOOSE ONTO THE TABLE CAUSING THE NEXT HUB TO RECEIVE A LARGER AMOUNT OF ADHESIVE WHICH MAY IN TURN CREATE A RUN OVER INTO THAT HUB AT WHICH TIME A CLOG COULD OCCUR. THE ADHESIVE NOZZLE OR FLOW IS NOT SET RIGHT.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PLUNGER OF A BD ULTRA-FINE¿ INSULIN SYRINGE WAS DIFFICULT TO PRESS. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154812 BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE INSULIN SYRINGE WITH NEEDLE FMF BD MEDICAL - DIABETES CARE 7121520

    Patients

    Seq Age Sex Outcome Treatment
    1 Other