BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENCAN PENCIL POINT SPINAL NEEDLES

    MDR report key: 3299442 · Received August 15, 2013

    Report

    Report Number
    2523676-2013-00247
    Event Type
    Injury
    Date Received
    August 15, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 14, 2013
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    BSP
    PMA / PMN Number
    K112515
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT # (B)(4). MULTIPLE F/U ATTEMPTS TO THE FACILITY TO OBTAIN ADD'L INFO WERE UNSUCCESSFUL. THE ACTUAL DEVICE INVOLVED IN THE REPORTED INCIDENT WAS NOT RETURNED FOR EVAL. W/O THE ACTUAL SAMPLE, A THOROUGH EVAL COULD NOT BE PERFORMED AND NO SPECIFIC CONCLUSIONS CAN BE DRAWN. HOWEVER, INCIDENTS OF THIS NATURE HAVE GENERALLY BEEN ATTRIBUTED TO THE NEEDLE BEING SUBJECTED TO SOME TYPE OF TRAUMA DURING USE THAT STRESSES THE DEVICE BEYOND ITS DESIGN CAPABILITIES. NO ADVERSE QUALITY TRENDS OF THIS NATURE WERE IDENTIFIED DURING THE COMPLAINT REVIEW PROCESS FOR THE PRODUCT CATALOG NUMBER IDENTIFIED IN THE REPORTED EVENT. THERE ARE NO OTHER REPORTS OF THIS NATURE AGAINST THE REPORTED LOT NUMBER. REVIEW OF THE NONCONFORMING LOT REPORT DATABASE PERFORMED FOR THE REPORTED LOT NUMBER DID NOT REVEAL ANY ABNORMALITIES OR NONCONFORMANCE OF THIS NATURE NOTED DURING IN-PROCESS OR FINAL PRODUCT INSPECTION. ALL AVAILABLE INFO HAS BEEN FORWARDED TO THE DEVICE MFR OF THE NEEDLE. IF ADD'L PERTINENT INFO BECOMES AVAILABLE, A F/U REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY THROUGH MEDWATCH # (B)(4): PT REC'D A SPINAL ANESTHETIC FOR A SCHEDULED ELECTIVE C-SECTION. IT WAS NOTED THE NEEDLE HAD BROKEN OFF. POST C-SECTION X-RAYS CONFIRMED RETAINED NEEDLE AT L-3/L-4. AFTER DELIVERY, SURGEON WENT IN AND RETRIEVED THE NEEDLE. NO PT HARM IN THE LONG RUN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393364 PENCAN PENCIL POINT SPINAL NEEDLES P2535 PENCAN SPINAL 25GA BSP B. BRAUN MEDICAL INC. P2535 0061070190

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R