BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPIDURAL CATHETERIZATION SET

    MDR report key: 13915357 · Received March 26, 2022

    Report

    Report Number
    3006425876-2022-00278
    Event Type
    Injury
    Date Received
    March 26, 2022
    Date of Event
    March 11, 2022
    Report Date
    March 11, 2022
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    BSO
    UDI-DI
    00801902029676
    PMA / PMN Number
    K140110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    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. THERE HAVE BEEN NO MATERIAL CHANGES FOR THIS PART DURING THE LAST TWO YEARS THAT COULD HAVE LED TO THIS COMPLAINT. 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. NO FURTHER ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    INVOLVED A FEMALE PATIENT WHO WAS IN MATERNITY ROOM. THE LOR SYRINGE DOES NOT IDENTIFY THE LOSS OF RESISTANCE DURING THE PROCEDURE OF INSERTION OF THE EPIDURAL CATHETER. WITH PHYSIOLOGICAL SALINE, THE SYRINGE STIFFENED AND RESISTANCE OCCURED LEADING TO A DURAL BREACH. ADDITIONAL INFORMATION: PATIENT WENT HOME. A BLOOD PATCH WAS APPLIED AND ANALGESICS PARACETAMOL PLUS IBUPROFENE. THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION.

    Description of Event or Problem · 0

    INVOLVED A FEMALE PATIENT WHO WAS IN MATERNITY ROOM. THE LOR SYRINGE DOES NOT IDENTIFY THE LOSS OF RESISTANCE DURING THE PROCEDURE OF INSERTION OF THE EPIDURAL CATHETER. WITH PHYSIOLOGICAL SALINE, THE SYRINGE STIFFENED AND RESISTANCE OCCURED LEADING TO A DURAL BREACH. ADDITIONAL INFORMATION: PATIENT WENT HOME. A BLOOD PATCH WAS APPLIED AND ANALGESICS PARACETAMOL PLUS IBUPROFEN. THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    979736 EPIDURAL CATHETERIZATION SET ANESTHESIA CONDUCTION CATHETER BSO ARROW INTERNATIONAL LLC IPN046311 71F21J1424 00801902029676

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown