BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE

    MDR report key: 7927309 · Received October 2, 2018

    Report

    Report Number
    1920898-2018-00759
    Event Type
    Malfunction
    Date Received
    October 2, 2018
    Date of Event
    September 9, 2018
    Report Date
    October 15, 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
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER RETURNED (1) LOOSE 1CC, 12.7MM SYRINGE. CUSTOMER STATES THAT A PIECE OF BLACK HAIR FOUND INSIDE THE BARREL. THE RETURNED SYRINGE WAS EXAMINED AND EXHIBITED A DARK STRAND OF MATERIAL INSIDE THE BARREL. A SMALL PORTION OF THIS MATERIAL WAS REMOVED FROM THE SAMPLE AND PREPARED FOR FTIR SPECTRAL ANALYSIS. THE ANALYSIS SHOWS THAT THIS MATERIAL IS MOST LIKELY A STRAND OF HAIR MIXED WITH SILICONE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 7241945. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE FIVE (5) NOTIFICATIONS (B)(4) 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. PROBABLE ROOT CAUSE IS LIKELY TO BE INEFFECTIVE GOWNING PROCEDURE BY AN ASSOCIATE DURING MANUFACTURING OF THIS PRODUCT. WHEN THIS TYPE OF EVENT OCCURS, HUMAN HAIRS AND DEBRIS MAY FIND IT'S WAY INTO THE PROCESS/PRODUCT WITHOUT DETECTION, RESULTING IN INSTANCES SUCH AS THOSE NOTED WITH THE RETURNED SAMPLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS "A PIECE OF BLACK HAIR" FOUND INSIDE THE BARREL OF THE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE. THERE WAS NO REPORT OF EXPOSURE, 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 THERE WAS "A PIECE OF BLACK HAIR" FOUND INSIDE THE BARREL OF THE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768310 BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 7241945

    Patients

    Seq Age Sex Outcome Treatment
    1 Other