BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 9242221 · Received October 25, 2019

    Report

    Report Number
    2618282-2019-00271
    Event Type
    Malfunction
    Date Received
    October 25, 2019
    Date of Event
    October 7, 2019
    Report Date
    November 19, 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 LOTS 8219864 TO INVESTIGATE FOR THIS RECORD. UNFORTUNATELY, AS A RESULT, BD WAS NOT ABLE TO VERIFY THE REPORTED ISSUE OR DETERMINE A DEFINITIVE ROOT CAUSE. THE MANUFACTURING RECORDS WERE REVIEWED FOR THE INCIDENT LOT AND NO DISCREPANCIES OR NON-CONFORMANCES WERE REPORTED THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION OF BENT NEEDLE NOR CONNECTIVITY. BASED ON THE DEVICE HISTORY REPORT REVIEW, NO MALFUNCTIONS, SUCH AS JAM, DAMAGE SENSORS WERE REPORTED. NEEDLES WITH ANGULARITY DISCREPANCIES ABOVE THE SPECIFICATION SHOULD PRESENTS DIFFICULTIES ON THE SHIELD ASSEMBLY PROCESS. MULTIPLE INSPECTION EFFORTS WERE COMPLETED TO COMPLY WITH STANDARDS AS PART OF ACCEPTANCE CRITERIA DISPOSITION. A CORRECTIVE ACTION PLAN, CAPA#(B)(4), HAS BEEN IMPLEMENTED FOR THE ASSEMBLY, PACKING, STORING AND HANDLING PROCESS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE NEEDLE SPINAL S/SU 25GA 3-1/2IN QUINCKE HAS BEEN FOUND EXPERIENCING LEAKAGE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: WHEN INTRODUCING THE DEVICE IN THE PATIENTS IN ORDER TO PERFORM THE THERAPY ON ONCOLOGIC PATIENTS, IT IS OBSERVED THE NEEDLE BENDS, OCCURRING LEAKAGE OF THE CYTOTOXIC MEDICATION.

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8219864, MEDICAL DEVICE EXPIRATION DATE: 2023-08-31, DEVICE MANUFACTURE DATE: 2018-09-10, MEDICAL DEVICE LOT #: 8123881, MEDICAL DEVICE EXPIRATION DATE: 2023-05-31, DEVICE MANUFACTURE DATE: 2018-06-11, 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 HAS BEEN REPORTED THAT THE NEEDLE SPINAL S/SU 25GA 3-1/2 IN QUINCKE HAS BEEN FOUND EXPERIENCING LEAKAGE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: WHEN INTRODUCING THE DEVICE IN THE PATIENTS IN ORDER TO PERFORM THE THERAPY ON ONCOLOGIC PATIENTS, IT IS OBSERVED THE NEEDLE BENDS, OCCURRING LEAKAGE OF THE CYTOTOXIC MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1037294 NEEDLE SPINAL S/SU 25GA 3-1/2IN QUINCKE ANESTHESIA CONDUCTION NEEDLE BSP BD CARIBE LTD. SEE H.10 30382904051809

    Patients

    Seq Age Sex Outcome Treatment
    1 Other