BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1 ML BD SAFETY-LOK¿ TB SYRINGE WITH 25 G X 5/8 IN. PERMANENTLY ATTACHED NEEDLE

    MDR report key: 6118464 · Received November 21, 2016

    Report

    Report Number
    1920898-2016-00040
    Event Type
    Injury
    Date Received
    November 21, 2016
    Date of Event
    November 8, 2016
    Report Date
    January 6, 2017
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMI
    PMA / PMN Number
    K944757
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: ON 12/22/2016, BD RECEIVED INFORMATION THAT THE CUSTOMER HAD SUBMITTED A MEDWATCH REPORT. THE REPORT # IS MW5066503. DEVICE EVALUATION: RESULTS: ALTHOUGH IT WAS INITIALLY REPORTED THAT A SAMPLE WOULD BE RETURNED, THE CUSTOMER DID NOT RETURN A SAMPLE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 5232744. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE. HOWEVER, CAPA (B)(4) HAS BEEN OPENED TO ADDRESS ISSUES RELATED TO THE NEEDLE PULLED OUT OF HUB & SAFETY MECHANISM LOOSE/SPINS FREELY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLE OF A 1 ML BD SAFETY-LOK TB SYRINGE WITH 25 G X 5/8 IN. PERMANENTLY ATTACHED NEEDLE CAME OFF OF THE SYRINGE IN A HEMODIALYSIS MEDICATION PORT. AS A RESULT, THERE WAS A CONTAMINATED NEEDLE STICK INJURY AND THE STAFF MEMBER RECEIVED MEDICAL TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767830 1 ML BD SAFETY-LOK¿ TB SYRINGE WITH 25 G X 5/8 IN. PERMANENTLY ATTACHED NEEDLE SAFETY ENGINEERED SYRINGE AND NEEDLE FMI BD MEDICAL - DIABETES CARE 5232744

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention