BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD QUINCKE SPINAL NEEDLES

    MDR report key: 17845957 · Received September 29, 2023

    Report

    Report Number
    2618282-2023-00074
    Event Type
    Malfunction
    Date Received
    September 29, 2023
    Date of Event
    September 15, 2023
    Report Date
    October 10, 2023
    Manufacturer
    BD CARIBE LTD.
    Product Code
    BSP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: THREE PHOTOS RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, IN THE FIRST PHOTO IT IS OBSERVED A NEEDLE ON A WHITE NAPKIN, RESIDUES OF SOME KIND OF GEL AND A SMEAR ON THE NAPKIN. IN THE SECOND PHOTO SEVERAL NEEDLES ARE SEEN WITH RESIDUE OF BLOOD AS SOME KIND OF GEL, ALSO SMALL SMEARS ARE OBSERVED, AND THE THIRD PHOTO SHOWS THE TYVEK WITH THE CATALOG¿S DATA. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 3041718, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO THE MANUFACTURING PROCESS AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD QUINCKE SPINAL NEEDLE HAD FOREIGN MATTER. THE FOLLOWING WAS RECEIVED FROM THE INITIAL REPORTER: TODAY WE USED BD SPINAL NEEDLE FOR THE APPLICATION OF BARRIGEL TO THE SPACE BETWEEN RECTUM AND PROSTATE. PRIMING THE NEEDLE WITH BARRIGEL WE FOUND SOME RESIDUAL METALLIC COLOURED SUBSTANCE ON GAUZE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD QUINCKE SPINAL NEEDLE HAD FOREIGN MATTER. THE FOLLOWING WAS RECEIVED FROM THE INITIAL REPORTER: TODAY WE USED BD SPINAL NEEDLE FOR THE APPLICATION OF BARRIGEL TO THE SPACE BETWEEN RECTUM AND PROSTATE. PRIMING THE NEEDLE WITH BARRIGEL WE FOUND SOME RESIDUAL METALLIC COLOURED SUBSTANCE ON GAUZE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353128 BD QUINCKE SPINAL NEEDLES ANESTHESIA CONDUCTION NEEDLE BSP BD CARIBE LTD. 3041718

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown