BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEEDLE SPINAL S/SU 18GA 6IN QUINCKE

    MDR report key: 9667274 · Received February 4, 2020

    Report

    Report Number
    2618282-2020-00004
    Event Type
    Injury
    Date Received
    February 4, 2020
    Date of Event
    December 18, 2019
    Report Date
    March 19, 2020
    Manufacturer
    BD CARIBE LTD.
    Product Code
    BSP
    UDI-DI
    30382904083602
    PMA / PMN Number
    SEE H.10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD HAS NOT BEEN PROVIDED WITH PHOTOS OR SAMPLES FOR CATALOG 408360 LOTS 8123805 AND 9088609 TO INVESTIGATE FOR THIS RECORD. UNFORTUNATELY, AS A RESULT, BD WAS UNABLE TO VERIFY THE REPORTED ISSUE OR DETERMINE A DEFINITIVE ROOT CAUSE. THE DEVICE HISTORY REVIEW WAS PERFORMED AND NO DISCREPANCIES WERE OBSERVED. THE MOST PROBABLE ROOT CAUSE IS RELATED TO OFF-LABEL USE OF THE PRODUCT. THE USE OF THE GUIDE WIRES ARE NOT APPLICABLE TO SPINAL NEEDLES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF NEEDLE SPINAL S/SU 18GA 6IN QUINCKE EXPERIENCED PRODUCT DAMAGE/DEFORMATION -DEVICE STILL OPERABLE, AND WERE INVOLVED IN A SERIOUS INJURY IN THE FORM OF MEDICAL INTERVENTION. DURING TREATMENT, A PORTION OF THE DEVICE BECAME EMBEDDED WITHIN THE PATIENT'S KIDNEY AND HAD TO BE REMOVED BY A HEALTH CARE PROFESSIONAL. NO ADDITIONAL INFORMATION REGARDING THE OUTCOME OF THIS MEDICAL INTERVENTION HAS BEEN SPECIFIED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE DEVICE IN QUESTION IS: AIG PL 150MM 18G 408360, REF: 408360 AND NUMBER OF SERIES: (B)(6). THE PROBLEM ENCOUNTERED IS: "DURING AN NLPC (NEPHROLITHOTOMY PER CUTANEOUS) USE OF THE SPINAL NEEDLE TO LOCATE THE KIDNEY. SMALLER NEEDLE DIAMETER AT THE END OF THE NEEDLE IMPEDING THE PASSAGE OF THE GUIDE THAT "SPINS" AND CAN'T REMOVE THE GUIDE." CLINICAL CONSEQUENCES: "RUPTURE OF PART OF THE GUIDE WIRE IN THE PATIENT'S KIDNEY. THIS PART HAD TO BE RECOVERED ".

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8123805, MEDICAL DEVICE EXPIRATION DATE: 2023-05-31, DEVICE MANUFACTURE DATE: 2018-07-02. MEDICAL DEVICE LOT #: 9088609, MEDICAL DEVICE EXPIRATION DATE: 2024-03-31, DEVICE MANUFACTURE DATE: 2019-05-29. PMA/510(K)#: PREAMENDMENT. 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 AN UNSPECIFIED NUMBER OF NEEDLE SPINAL S/SU 18GA 6IN QUINCKE EXPERIENCED PRODUCT DAMAGE/DEFORMATION -DEVICE STILL OPERABLE, AND WERE INVOLVED IN A SERIOUS INJURY IN THE FORM OF MEDICAL INTERVENTION. DURING TREATMENT, A PORTION OF THE DEVICE BECAME EMBEDDED WITHIN THE PATIENT'S KIDNEY AND HAD TO BE REMOVED BY A HEALTH CARE PROFESSIONAL. NO ADDITIONAL INFORMATION REGARDING THE OUTCOME OF THIS MEDICAL INTERVENTION HAS BEEN SPECIFIED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE DEVICE IN QUESTION IS: AIG PL 150MM 18G 408360, REF: 408360 AND NUMBER OF SERIES: 8123805 AND 9088609. THE PROBLEM ENCOUNTERED IS: "DURING AN NLPC (NEPHROLITHOTOMY PER CUTANEOUS) USE OF THE SPINAL NEEDLE TO LOCATE THE KIDNEY. SMALLER NEEDLE DIAMETER AT THE END OF THE NEEDLE IMPEDING THE PASSAGE OF THE GUIDE THAT "SPINS" AND CAN'T REMOVE THE GUIDE." CLINICAL CONSEQUENCES: "RUPTURE OF PART OF THE GUIDE WIRE IN THE PATIENT'S KIDNEY. THIS PART HAD TO BE RECOVERED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131341 NEEDLE SPINAL S/SU 18GA 6IN QUINCKE ANESTHESIA CONDUCTION NEEDLE BSP BD CARIBE LTD. 408360 SEE H.10 30382904083602

    Patients

    Seq Age Sex Outcome Treatment
    1 Other