BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3 ML BD PRESET SYRINGE WITH BD LUER-LOK TIP

    MDR report key: 4491357 · Received February 2, 2015

    Report

    Report Number
    2243072-2015-00013
    Event Type
    Injury
    Date Received
    February 2, 2015
    Date of Event
    January 12, 2015
    Report Date
    February 2, 2015
    Manufacturer
    BD
    Product Code
    JKA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE FULL NAME OF THE DEVICE IS: 3 ML BD PRESET SYRINGE WITH BD LUER-LOK TIP. 22 G X 1 IN BD ECLIPSE NEEDLE. RESULTS: A SAMPLE IS NOT AVAILABLE FOR EVALUATION. TWENTY RETAINED SAMPLES FROM THE SAME LOT NUMBER WERE TAKE AT RANDOM, AND DRAWN WITH DEIONIZED WATER. THE SAFETY SHIELDS WERE THEN ACTIVATED, AND IN ALL 20 CASES, THE SHIELD CORRECTLY CLICKED IN PLACE OVER THE NEEDLE. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF REPORTED LOT NUMBER 4161232. CONCLUSIONS: WITHOUT AN ACTUAL SAMPLE TO EXAMINE, AND AS RETAINED SAMPLES MET MANUFACTURING STANDARDS, A ROOT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER WITHDRAWING BLOOD FROM A (B)(6) SOURCE (B)(6) PATIENT WITH A 3ML BD PRESET SYRINGE WITH BD LUER-LOK TIP, THE NURSE ACTIVATED THE SAFETY MECHANISM AND HEARD A "CLICK", BUT THE NEEDLE DID NOT FULLY RETRACT. BECAUSE OF THE NEEDLE RETRACTION FAILURE, THE NURSE OBTAINED A NEEDLE STICK INJURY. IMMEDIATELY THEREAFTER, THE NURSE STARTED A PROPHYLACTIC (B)(6) TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73519 3 ML BD PRESET SYRINGE WITH BD LUER-LOK TIP BLOOD GAS ANALYSIS SYRINGE JKA BD 4161232

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention