BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPROTTE

    MDR report key: 4109147 · Received September 8, 2014

    Report

    Report Number
    9611612-2014-00015
    Event Type
    Injury
    Date Received
    September 8, 2014
    Date of Event
    March 25, 2014
    Report Date
    September 8, 2014
    Manufacturer
    PAJUNK GMBH MEDIZINTECHNOLOGIE
    Product Code
    BSP
    PMA / PMN Number
    K911260
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO SPECIFIC CORRECTIVE ACTION DUE TO MITIGATIVE PREVENTION OF HAZARDS IS ASSIGNED TO THIS REPORT. A RANDOMIZED REVIEW OF THE RELEVANT RECORDS AND THE RAW MATERIAL FILES OF THE MFG BATCHES DID NEITHER INDICATE RECORDED QUALITY PROBLEMS NOR REFECTIONS RELATED TO THIS INCIDENT. THIS INFO IS BEING SUBMITTED TO COMPLY WITH THE REQUIREMENTS OF 21 CFR 803. THE INFO IN THIS REPORT IS NOT AN ADMISSION THAT THIS DEVICE OR ANY OTHER DEVICE DISTRIBUTED BY (B)(4) IS OR WAS DEFECTIVE OR DANGEROUS IN ANY WAY, OR CAUSED OR CONTRIBUTED TO ANY PT INJURY. IF ANY FURTHER INFO IS BECOMING AVAILABLE, MFR IMMEDIATELY WILL INFORM FDA. IF NO FURTHER INFO BECOMES AVAILABLE, MFR CONSIDERS THIS FILE TO BE CLOSED.

    Description of Event or Problem · 1

    (B)(4). EVENT TOOK PLACE IN (B)(6) AND HAS BEEN REPORTED TO (B)(4). DESCRIPTION OF THE CUSTOMER: NEEDLE BROKE WITHIN PATIENT AFTER DIAGNOSTIC LUMBAR PUNCTURE, REQUIRED SURGICAL INTERVENTION TO RETRIEVE FRAGMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551369 SPROTTE 868.5150 ANESTHESIA CONDUCTION NEEDLE BSP PAJUNK GMBH MEDIZINTECHNOLOGIE

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention