BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD VACUTAINAER PRECISIONGLIDE SAMPLE NEEDLE

    MDR report key: 4990516 · Received August 4, 2015

    Report

    Report Number
    2243072-2015-00161
    Event Type
    Injury
    Date Received
    August 4, 2015
    Date of Event
    June 15, 2015
    Report Date
    August 4, 2015
    Manufacturer
    B D
    Product Code
    JKA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE IS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT NUMBER 4273293. CONCLUSION: W/OUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE FILLING A COLLECTION BOX W/BD VACUTAINER PRECISIONGLIDE SAMPLE NEEDLES, A CLINICIAN RECEIVED A NEEDLE STICK INJURY FROM A CLEAN NEEDLE BECAUSE THE NEEDLE DID NOT HAVE A SHIELD ON IT. ALTHOUGH THE NEEDLE WAS NOT USED, THE CLINICIAN RECEIVED ROUTINE POST EXPOSURE LAB WORK, THE RESULTS OF WHICH WERE NEGATIVE, AND WAS GIVEN "(B)(6)" MEDICATION BY A PHYSICIAN. OF NOTE, THIS COMPLAINT WAS INITIALLY REPORTED AS A MISSING COMPONENT ON (B)(6) 2015, AND THE DECISION WAS MADE THAT THE COMPLAIN WAS NOT REPORTABLE ON (B)(6) 2015. ON 06/01/2015, ADD'L INFO WAS RECEIVED INDICATING THAT A CLEAN NEEDLE STICK INJURY OCCURRED AND THAT PROPHYLACTIC TREATMENT WAS GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511459 BD VACUTAINAER PRECISIONGLIDE SAMPLE NEEDLE BLOOD COLLECTION NEEDLE JKA B D 4273293

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention