BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIDURAL CATHETERIZATION SET

    MDR report key: 14606494 · Received June 6, 2022

    Report

    Report Number
    3006425876-2022-00537
    Event Type
    Malfunction
    Date Received
    June 6, 2022
    Date of Event
    May 24, 2022
    Report Date
    May 24, 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.

    Additional Manufacturer Narrative · 0

    (B)(4). A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE EPIDURAL CATHETER AND EPIDURAL NEEDLE WITH NO RELEVANT FINDINGS. THE CUSTOMER REPORTED DIFFICULTY ADVANCING THE CATHETER INTO THE PATIENT. THE CUSTOMER RETURNED ONE OPENED KIT. THE EPIDURAL CATHETER WAS REMOVED. NO EPIDURAL NEEDLE WAS RETURNED. THE RETURNED CATHETER WAS VISUALLY EXAMINED WITH AND WITHOUT MAGNIFICATION. VISUAL EXAMINATION OF THE RETURNED CATHETER REVEALED THE CATHETER APPEARS USED. BIOLOGICAL MATERIAL CAN BE SEEN BETWEEN THE INNER COILS. NO OTHER DEFECTS OR ANOMALIES WERE OBSERVED. A DIMENSIONAL INSPECTION WAS PERFORMED ON THE RETURNED EPIDURAL CATHETER. THE OUTER DIAMETER (OD) OF THE RETURNED CATHETER MEASURED 1.05MM (CALIPER: (B)(4)) WHICH IS WITHIN THE SPECIFICATION OF A MAXIMUM OF 1.115MM PER GRAPHIC KZ-05400-030; REV 5. A FUNCTIONAL TEST WAS PERFORMED BY ATTEMPTING TO THREAD THE RETURNED CATHETER THROUGH A LAB INVENTORY EPIDURAL NEEDLE. THE CATHETER WAS THREADED AT THE DISTAL END AND WOULD THREAD THROUGH THE EPIDURAL NEEDLE WITH NO RESISTANCE MET. A DRAG TEST WAS PERFORMED PER PIP-013; REV 5 USING THE RETURNED CATHETER, A LAB INVENTORY NEEDLE, AND A WEIGHT (REF-002579). THE RETURNED CATHETER COULD THREAD THROUGH THE LAB INVENTORY NEEDLE WITH NO RESISTANCE MET. THE RETURNED CATHETER AND LAB INVENTORY NEEDLE PASSED THE DRAG TEST. SPECIFICATIONS PER GRAPHIC KZ-05400-030; REV 5 WAS REVIEWED AS A PART OF THIS COMPLAINT INVESTIGATION. A DESIGN HISTORY REVIEW WAS PERFORMED FOR PART # KZ-05400-030 AND RZ-05400-006 AS A PART OF THIS COMPLAINT INVESTIGATION. THERE HAVE BEEN NO MATERIAL CHANGES FOR THESE PARTS 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 THE SAMPLE RECEIVED. THE REPORTED COMPLAINT OF DIFFICULTY ADVANCING THE CATHETER INTO THE PATIENT COULD NOT BE CONFIRMED BASED ON THE SAMPLE RECEIVED. THE CUSTOMER RETURNED ONE EPIDURAL CATHETER. HOWEVER, THE EPIDURAL NEEDLE WAS NOT RETURNED. THE RETURNED CATHETER COULD BE THREADED THROUGH A LAB INVENTORY NEEDLE WITH NO RESISTANCE MET. THE RETURNED CATHETER PASSED A FUNCTIONAL DRAG TEST, AND THE RETURNED CATHETER OD WAS FOUND TO BE WITHIN SPECIFICATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE EPIDURAL CATHETER AND EPIDURAL NEEDED WITH NO RELEVANT FINDINGS. HOWEVER, THIS COMPLAINT INVESTIGATION COULD NOT BE DETERMINED BASED UPON THE INFORMATION PROVIDED AND THE SAMPLE RECEIVED. NO FURTHER ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    SEVERAL KITS FACED AN ISSUE. ANESTHETISTS HAVE GREAT DIFFICULTY ADVANCING THE CATHETER ONCE THE NEEDLE IS IN PLACE. SEVERAL CATHETERS COULD NOT BE INSERTED AND OTHERS NEEDED ADDITIONAL FORCE DURING INSERTION.

    Description of Event or Problem · 0

    SEVERAL KITS FACED AN ISSUE. ANESTHETISTS HAVE GREAT DIFFICULTY ADVANCING THE CATHETER ONCE THE NEEDLE IS IN PLACE. SEVERAL CATHETERS COULD NOT BE INSERTED AND OTHERS NEEDED ADDITIONAL FORCE DURING INSERTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1141640 EPIDURAL CATHETERIZATION SET ANESTHESIA CONDUCTION CATHETER BSO ARROW INTERNATIONAL LLC IPN046311 71F22A2313 00801902029676

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown