BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIDURAL CATHETERIZATION SET

    MDR report key: 9395245 · Received December 2, 2019

    Report

    Report Number
    3006425876-2019-01016
    Event Type
    Malfunction
    Date Received
    December 2, 2019
    Date of Event
    November 25, 2019
    Report Date
    November 26, 2019
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    CAZ
    PMA / PMN Number
    K103658
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED AS NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. 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: A. CHANGED PLUNGER MATERIAL FROM PROFAX 535 TO PROFAX 531 B. CHANGED TO NEW PLUNGER TOOL C. CHANGED TO NEW MOLD FOR BLUE STOPPER D. CHANGED MOLDING LOCATION FOR THE PLUNGER AND THE BLUE STOPPER AS FOLLOWS. - PLUNGER: FROM FLEIMAPLASTIC IN GERMANY TO (B)(6), GERMANY - BLUE STOPPER: FROM ET, GERMANY TO (B)(6), 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 COULD NOT BE PERFORMED AS NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. 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 THERE WAS LOSS OF LIQUIDS BETWEEN THE PISTON AND THE INNER WALLS OF THE SYRINGE.

    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 THERE WAS LOSS OF LIQUIDS BETWEEN THE PISTON AND THE INNER WALLS OF THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1193235 EPIDURAL CATHETERIZATION SET ANESTHESIA CONDUCTION KIT CAZ ARROW INTERNATIONAL INC. UNKN

    Patients

    Seq Age Sex Outcome Treatment
    1 N/A.