BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE¿ NEEDLE

    MDR report key: 9444592 · Received December 10, 2019

    Report

    Report Number
    1213809-2019-01244
    Event Type
    Malfunction
    Date Received
    December 10, 2019
    Date of Event
    November 12, 2019
    Report Date
    January 13, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    30382903059165
    PMA / PMN Number
    K951254
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: IV CATHETER SYSTEM WAS RECEIVED P/N 383536, BATCH #9233234. SINCE NO SAMPLES DISPLAYING THE REPORTED CONDITION WERE RECEIVED NO DEFECTS COULD BE CONFIRMED. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER 8324521 THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SAFETYGLIDE¿ NEEDLE LEAKED. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 305916; BATCH NO. 8324521. IT WAS REPORTED THAT LEAKAGE ON SIDE OF NEEDLE. WAS GIVING FLU SHOT AND NEEDLE MALFUNCTIONED- MEDICATION CAME OUT OF SIDE OF NEEDLE INSTEAD OF INJECTING- NEEDLE WAS SECURELY ATTACHED TO SYRINGE.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD SAFETYGLIDE¿ NEEDLE LEAKED. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 305916 BATCH NO. 8324521. IT WAS REPORTED THAT LEAKAGE ON SIDE OF NEEDLE. WAS GIVING FLU SHOT AND NEEDLE MALFUNCTIONED- MEDICATION CAME OUT OF SIDE OF NEEDLE INSTEAD OF INJECTING- NEEDLE WAS SECURELY ATTACHED TO SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1243261 BD SAFETYGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 305916 8324521 30382903059165

    Patients

    Seq Age Sex Outcome Treatment
    1 Other