BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW SPINAL ANESTHESIA KIT: 25 GA X 9 CM

    MDR report key: 18254253 · Received December 4, 2023

    Report

    Report Number
    9680794-2023-00927
    Event Type
    Malfunction
    Date Received
    December 4, 2023
    Date of Event
    November 7, 2023
    Report Date
    November 8, 2023
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    BSP
    UDI-DI
    10801902064070
    PMA / PMN Number
    K911260
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4), THE REPORTED COMPLAINT OF THE MEDICATION BEING INEFFECTIVE COULD NOT BE CONFIRMED. THE POTENCY OF THE BUPIVACAINE MET SPECIFICATIONS ACCORDING TO THE MANUFACTURE'S COA. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE BUPIVACAINE AMPULE WITH NO EVIDENCE TO SUGGEST A MANUFACTURING RELATED CAUSE. THEREFORE, THE POTENTIAL CAUSE OF THIS COMPLAINT COULD NOT BE DETERMINED. NO FURTHER ACTION IS REQUIRED AT THIS TIME. TELEFLEX WILL CONTINUE TO MONITOR AND TREND ON COMPLAINTS OF THIS NATURE.

    Additional Manufacturer Narrative · 0

    (B)(4)

    Description of Event or Problem · 0

    THERE WERE 3 INSTANCES WHERE THE DRUG DIDN'T MAKE OR KEEP THE PATIENT NUMB, IT HAPPENED WITH DIFFERENT PROVIDERS. ASSOCIATED TO 9680794-2023-00928 AND 9680794-2023-00926.

    Description of Event or Problem · 0

    THERE WERE 3 INSTANCES WHERE THE DRUG DIDN'T MAKE OR KEEP THE PATIENT NUMB, IT HAPPENED WITH DIFFERENT PROVIDERS. ASSOCIATED TO 9680 794-2023-00928 AND 9680794-2023-00926.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1283756 ARROW SPINAL ANESTHESIA KIT: 25 GA X 9 CM NEEDLE, CONDUCTION, ANESTHETI BSP ARROW INTERNATIONAL LLC 33F23F0069 10801902064070

    Patients

    Seq Age Sex Outcome Treatment
    1 Female NOT REPORTED| NOT REPORTED