BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD INTEGRA¿ 3ML SYRINGE WITH DETACHABLE NEEDLE

    MDR report key: 5001229 · Received August 10, 2015

    Report

    Report Number
    1213809-2015-00002
    Event Type
    Injury
    Date Received
    August 10, 2015
    Date of Event
    July 16, 2015
    Report Date
    September 9, 2015
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    PMA / PMN Number
    K010188
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE AVAILABLE FOR EVALUATION?: NO - A SAMPLE WAS NOT RETURNED FOR EVALUATION. IT WAS PREVIOUSLY REPORTED THAT A SAMPLE WOULD BE RETURNED. A SAMPLE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT NUMBER 3024278. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED. DEVICE NOT RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    A SAMPLE IS AVAILABLE FOR EVAL. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. PIR #(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING A BD INTEGRA ML SYRINGE WITH DETACHABLE NEEDLE, THE NEEDLE DID NOT RETRACT AND THE NURSE RECEIVED A CONTAMINATED NEEDLE STICK INJURY. THE NURSE RECEIVED ANTIVIRAL POST-EXPOSURE PROPHYLAXIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING A BD INTEGRA 3ML SYRINGE WITH DETACHABLE NEEDLE, THE NEEDLE DID NOT RETRACT AND THE NURSE REC'D A CONTAMINATED NEEDLE STICK INJURY. THE NURSE REC'D ANTIVIRAL POST-EXPOSURE PROPHYLAXIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522865 BD INTEGRA¿ 3ML SYRINGE WITH DETACHABLE NEEDLE HYPODERMIC SYRINGE FMI BECTON DICKINSON MEDICAL SYSTEMS 3024278

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention