BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE SPINAL S/SU 25GA 3-1/2IN QUINCKE

    MDR report key: 8457994 · Received March 27, 2019

    Report

    Report Number
    2618282-2019-00153
    Event Type
    Malfunction
    Date Received
    March 27, 2019
    Date of Event
    March 12, 2019
    Report Date
    April 17, 2019
    Manufacturer
    BD CARIBE LTD.
    Product Code
    BSP
    UDI-DI
    30382904051809
    PMA / PMN Number
    PREAMENDMENT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD HAS NOT BEEN PROVIDED WITH PHOTOS OR SAMPLES FOR CATALOG 405180, LOT 8123881 TO INVESTIGATE FOR THIS RECORD. UNFORTUNATELY, AS A RESULT, BD WAS UNABLE TO VERIFY THE REPORTED ISSUES. BD NEEDLES GO THROUGH MULTIPLE INSPECTIONS TO COMPLY WITH STANDARDS AND AS PART OF ACCEPTANCE CRITERIA DISPOSITION. NO ISSUES OR DISCREPANCIES WERE REPORTED FOR THE REPORTED BATCH AND LEAK TESTS WERE PERFORMED WITH SUCCESSFUL RESULTS. IN REGARDS TO THE NEEDLE FLEXIBILITY CONDITION, NEEDLES USED FOR THE COMPLAINT LOT WERE REVIEWED AND A COMPLETE INSPECTION FOR THE CANNULA WERE APPROVED ON JAN 2018.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A NEEDLE SPINAL S/SU 25GA 3-1/2IN QUINCKE HAD LEAKAGE. THE FOLLOWING WAS REPORTED, "AT THE TIME OF ADMINISTERING INTRATHECAL ONCOLOGICAL MEDICATION, THE SYRINGE DOES NOT TIE WITH THE SPINAL NEEDLE HUB SO THE MEDICATION LEAKS, ALSO IN THE PUNCTURE IS VERY SOFT."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A NEEDLE SPINAL S/SU 25GA 3-1/2IN QUINCKE HAD LEAKAGE. THE FOLLOWING WAS REPORTED, "AT THE TIME OF ADMINISTERING INTRATHECAL ONCOLOGICAL MEDICATION, THE SYRINGE DOES NOT TIE WITH THE SPINAL NEEDLE HUB SO THE MEDICATION LEAKS, ALSO IN THE PUNCTURE IS VERY SOFT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247965 NEEDLE SPINAL S/SU 25GA 3-1/2IN QUINCKE ANESTHESIA CONDUCTION NEEDLE BSP BD CARIBE LTD. 8123881 30382904051809

    Patients

    Seq Age Sex Outcome Treatment
    1 Other