BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIDURAL CATHETERIZATION SET

    MDR report key: 9470290 · Received December 13, 2019

    Report

    Report Number
    3006425876-2019-01057
    Event Type
    Malfunction
    Date Received
    December 13, 2019
    Date of Event
    December 3, 2019
    Report Date
    December 3, 2019
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    BSO
    PMA / PMN Number
    K140110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE LOR SYRINGE WITH NO RELEVANT FINDINGS. A DESIGN HISTORY REVIEW WAS PERFORMED FOR PART # KZ-05501-002 AS A PART OF THIS COMPLAINT INVESTIGATION. PER ECO-051699 (RELEASED 03-DEC-2018), SUPPLIER (PREOX) MADE THE FOLLOWING CHANGES: KZ-05501-002 LUER PLASTIC LOR SYRINGE: CHANGED PLUNGER MATERIAL FROM PROFAX 535 TO PROFAX 531. CHANGED TO NEW PLUNGER TOOL. CHANGED TO NEW MOLD FOR BLUE STOPPER. CHANGED MOLDING LOCATION FOR THE PLUNGER AND THE BLUE STOPPER AS FOLLOWS. PLUNGER: FROM FLEIMAPLASTIC IN GERMANY TO GPE, GERMANY. BLUE STOPPER: FROM ET, GERMANY TO PSILKON, GERMANY. THESE EFFECTIVE CHANGES DID IMPACT PRODUCT DESIGN AND MATERIAL. A CORRECTIVE ACTION IS NOT REQUIRED AT THIS TIME AS THE ROOT CAUSE FOR THIS COMPLAINT INVESTIGATION COULD NOT BE DETERMINED BASED UPON THE INFORMATION PROVIDED AND WITHOUT THE ACTUAL SAMPLE. COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS PROVIDED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE LOR SYRINGE WITH NO EVIDENCE TO SUGGEST A MANUFACTURING RELATED CAUSE. THEREFORE, THE POTENTIAL CAUSE OF THIS COMPLAINT COULD NOT BE DETERMINED BASED UPON THE INFORMATION PROVIDED AND WITHOUT THE SAMPLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PLUNGER OF THE LOR SYRINGE IS LEAKING.

    Additional Manufacturer Narrative · 1

    QN#: (B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PLUNGER OF THE LOR SYRINGE IS LEAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1261644 EPIDURAL CATHETERIZATION SET ANESTHESIA CONDUCTION CATHETER BSO ARROW INTERNATIONAL INC. IPN038182 71F19G0974

    Patients

    Seq Age Sex Outcome Treatment
    1