BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1 ML BD SAFETY-LOK¿ U-100 INSULIN SYRINGE, 9GX1/2" BD ULTRA-FINE¿ NEEDLE

    MDR report key: 5674077 · Received May 23, 2016

    Report

    Report Number
    1920898-2016-00017
    Event Type
    Injury
    Date Received
    May 23, 2016
    Date of Event
    May 5, 2016
    Report Date
    June 6, 2016
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K941657
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: N/A. A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    RESULTS: BOTH SEALED AND UNSEALED SAMPLES WERE RETURNED FOR EVALUATION. A VISUAL INSPECTION REVEALED THAT ON THE DEFECTIVE SAMPLES THE HUB IS BROKEN AROUND THE FLANGE OF THE HUB PREVENTING THE SAFETY FEATURE FROM ENGAGING UPON ATTEMPTED ACTIVATION AND THAT THE ENTIRE HUB BREAKS OFF IN THE SAFETY SLEEVE. IN ADDITION, ON MOST OF THE SAMPLES THERE IS SIGNIFICANT CORK DAMAGE ON THE HUB. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 5162602. CONCLUSION: BASED ON THE PRELIMINARY INVESTIGATION, IT IS LIKELY THE CONDITION THAT CAUSED THE CRACKED HUB/HUB DISENGAGEMENT OCCURRED AT THE (B)(4) MANUFACTURING PLANT AT THE SAFETY LOK ASSEMBLY OPERATION WHICH ASSEMBLES ALL COMPONENTS OF THE SYRINGE. CAPA (B)(4) HAS BEEN OPENED TO INVESTIGATE THE ROOT CAUSE FOR THE BROKEN HUBS. IF ADDITIONAL INFORMATION IS PROVIDED AFTER THE CAPA COMPLETION DATE OF 8/18/2016, A SECOND SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A NURSE OBTAINED A CONTAMINATED NEEDLE STICK INJURY FROM A 1 ML BD SAFETY-LOK¿ U-100 INSULIN SYRINGE WITH 9 G X 1/2 IN. BD ULTRA-FINE¿ NEEDLE AFTER ACTIVATING THE SAFETY DEVICE. AS THE SAFETY MECHANISM WAS ACTIVATED, THE NEEDLE SEPARATED FROM THE HUB AND THE NURSE WAS STUCK BY THE USED/CONTAMINATED NEEDLE. THE NURSE RECEIVED POST EXPOSURE LAB WORK. THE TEST RESULTS WERE NEGATIVE AND THE NURSE DID NOT RECEIVE ANY PROPHYLAXIS OR OTHER MEDICATIONS. THE NURSE WILL ALSO RECEIVE FOLLOW UP LAB WORK AT ONE AND FOUR MONTH INTERVALS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327418 1 ML BD SAFETY-LOK¿ U-100 INSULIN SYRINGE, 9GX1/2" BD ULTRA-FINE¿ NEEDLE SYRINGE AND NEEDLE FMF BD MEDICAL - DIABETES CARE 5162602

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention