BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE¿ NEEDLE

    MDR report key: 8683745 · Received June 10, 2019

    Report

    Report Number
    1213809-2019-00602
    Event Type
    Malfunction
    Date Received
    June 10, 2019
    Date of Event
    May 18, 2019
    Report Date
    May 23, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    30382903059028
    PMA / PMN Number
    K951254
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: SEVEN SEALED SAFETYGLIDE NEEDLES WERE RECEIVED, CONFIRMED TO BE FROM BATCH #8143729 (MATERIAL 305902). EACH NEEDLE WAS TAKEN OUT OF THE PACKAGE AND VISUALLY EVALUATED. NO VISUAL DEFECTS WERE OBSERVED. EACH NEEDLE WAS THEN ATTACHED TO A 3ML SYRINGE AND HAD ITS SAFETY SHIELD ACTIVATED TO TEST FUNCTION. ALL SAFETY SHIELDS ACTIVATED AS EXPECTED WITHOUT ISSUES. NO DEFECTS WERE OBSERVED. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. INVESTIGATION CONCLUSION: THE REPORTED DEFECT WAS NOT IDENTIFIED IN THE SAMPLES RECEIVED. ROOT CAUSE DESCRIPTION: N/A. RATIONALE: THE REPORTED DEFECT WAS NOT IDENTIFIED IN THE SAMPLES RECEIVED.

    Description of Event or Problem · 1

    MATERIAL NO.: 305902, BATCH NO.: UNKNOWN. IT WAS REPORTED THAT AFTER USE OF THE BD SAFETYGLIDE¿ NEEDLE THE SAFETY MECHANISM WAS STUCK AND RESISTING TO LOCK RESULTING IN A NEEDLE STICK TO THE LEFT THUMB OF THE NURSE. NURSE RECEIVED BLOOD WORK AND IS TAKING PROPHYLAXIS; PATIENT ALSO AGREED TO BLOOD WORK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: SAFETY MECHANISM WAS STUCK AND RESISTING TO LOCK; NEEDLE STICK OCCURRED ON THE LEFT THUMB WITH A USED NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478870 BD SAFETYGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 8143729 30382903059028

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention