BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIDURAL CATHETERIZATION SET

    MDR report key: 9246661 · Received October 28, 2019

    Report

    Report Number
    3006425876-2019-00887
    Event Type
    Malfunction
    Date Received
    October 28, 2019
    Date of Event
    October 18, 2019
    Report Date
    October 28, 2019
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    CAZ
    PMA / PMN Number
    K103658
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    QN# (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 MOLD FOR BLUE STOPPER. CHANGED MOLDING LOCATION FOR THE PLUNGER AND THE BLUE STOPPER AS FOLLOWS. PLUNGER: FROM FLEIMAPLASTIC IN GERMANY TO GPE, GERMANYBLUE STOPPER: FROM (B)(6) TO (B)(6). 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.

    Additional Manufacturer Narrative · 1

    (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 DURING THE INSERTION OF THE EPIDURAL, THE NACL WAS ABOUT TO BE INFUSED BUT THE SYRINGE KEEPS LEAKING BY THE PLUNGER. CLINICAL CONSEQUENCES: RISK FOR THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE INSERTION OF THE EPIDURAL, THE NACL WAS ABOUT TO BE INFUSED BUT THE SYRINGE KEEPS LEAKING BY THE PLUNGER. CLINICAL CONSEQUENCES: RISK FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1041917 EPIDURAL CATHETERIZATION SET ANESTHESIA CONDUCTION KIT CAZ ARROW INTERNATIONAL INC. 71F19G1028

    Patients

    Seq Age Sex Outcome Treatment
    1