BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIDURAL CATHETERIZATION SETS

    MDR report key: 9617857 · Received January 22, 2020

    Report

    Report Number
    1036844-2020-00033
    Event Type
    Malfunction
    Date Received
    January 22, 2020
    Date of Event
    January 20, 2020
    Report Date
    January 21, 2020
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    BSO
    PMA / PMN Number
    K140110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4). A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE EPIDURAL CATHETER AND NEEDLE WITH NO RELEVANT FINDINGS. THE CUSTOMER REPORTED THE CATHETER WOULD NOT THREAD THROUGH THE EPIDURAL NEEDLE. THE CUSTOMER RETURNED ONE EPIDURAL NEEDLE W/STYLET AND GUARD. NO EPIDURAL CATHETER WAS RETURNED (REFERENCE FILES (B)(4)). THE RETURNED NEEDLE WAS VISUALLY EXAMINED WITH AND WITHOUT MAGNIFICATION. VISUAL EXAMINATION OF THE RETURNED NEEDLE REVEALED THAT THE NEEDLE APPEARS TYPICAL. THE NEEDLE CANNULA APPEARS TYPICAL. MICROSCOPIC EXAMINATION REVEALED THE NEEDLE BEVEL APPEARS POLISHED AND SMOOTH WITH NO OBSERVED BURRS; HOWEVER, A CLEAR SUBSTANCE CAN BE SEEN IN THE BEVEL (REFERENCE FILES (B)(4). ). IT CANNOT BE DETERMINED IF THE SUBSTANCE IS BIOLOGICAL MATERIAL. NO OTHER DEFECTS OR ANOMALIES WERE OBSERVED. A DIMENSIONAL INSPECTION WAS PERFORMED ON THE RETURNED EPIDURAL NEEDLE. THE ID MEASURED 0.046IN (1.17MM) ((B)(4). ), WHICH IS WITHIN SPECIFICATION OF 1.17MM PER GRAPHIC KZ-05500-007; REV 9. A FUNCTIONAL TEST WAS PERFORMED BY ATTEMPTING TO THREAD A LAB INVENTORY CATHETER THROUGH THE RETURNED EPIDURAL NEEDLE. THE CATHETER WAS THREAD AT THE DISTAL END AND WOULD THREAD THROUGH THE EPIDURAL NEEDLE UNTIL IT REACHED THE BEVEL OF NEEDLE'S TIP. AS MENTIONED IN THE VISUAL INSPECTION, THERE WAS A SUBSTANCE IN THE BEVEL. THE CATHETER HESITATES WITH THE SUBSTANCE IN THE BEVEL; HOWEVER, WITH A LITTLE FORCE OF THE CATHETER, THE CATHETER WILL THREAD COMPLETELY THROUGH THE NEEDLE ONCE THE DISTAL TIP WAS PASSED THE SUBSTANCE IN THE BEVEL WITH NO RESISTANCE. A DRAG TEST PER PIP-013 USING A WEIGH (B)(4) COULD ALSO BE PERFORMED WITH NO ISSUE ONCE THE DISTAL TIP WAS PASSED THE SUBSTANCE IN THE BEVEL. SPECIFICATIONS PER GRAPHIC KZ-05500-007, REV 9 WERE REVIEWED AS A PART OF THIS COMPLAINT INVESTIGATION. A DESIGN HISTORY REVIEW WAS PERFORMED FOR PART # KZ-05500-007 AND KZ-05400-030 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 CONDITION OF THE SAMPLE RECEIVED. THE REPORTED COMPLAINT THAT THE CATHETER WOULD NOT THREAD THROUGH THE NEEDLE WAS CONFIRMED BASED ON THE SAMPLE RECEIVED. ONLY AN EPIDURAL NEEDLE WAS RETURNED, A CATHETER WAS NOT RETURNED. DURING MICROSCOPIC EXAMINATION, A SUBSTANCE COULD BE SEEN IN THE BEVEL OF THE RETURNED NEEDLE'S TIP. THIS WOULD CAUSE A HESITATION OF THE CATHETER WHEN THREADING. WITH LITTLE FORCE OF THE CATHETER, THE CATHETER WOULD COMPLETELY THREAD THROUGH THE NEEDLE AS WELL AS PASS A DRAG TEST WITH NO ISSUE. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE EPIDURAL CATHETER AND NEEDLE WITH NO RELEVANT FINDINGS. IT IS UNKNOWN HOW THE NEEDLE WAS HANDLED PRIOR TO AND DURING USE. IT ALSO CANNOT BE DETERMINED IF THE MATERIAL FOUND WAS BIOLOGICAL. THEREFORE, THE POTENTIAL CAUSE OF THIS COMPLAINT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CATHETER WOULD NOT PASS THROUGH THE NEEDLE. THEY HAD TO POKE THE PATIENT TWICE.

    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 THE CATHETER WOULD NOT PASS THROUGH THE NEEDLE. THEY HAD TO POKE THE PATIENT TWICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80327 EPIDURAL CATHETERIZATION SETS CATHETER, CONDUCTION, ANESTHE BSO ARROW INTERNATIONAL INC. 13F19F0303

    Patients

    Seq Age Sex Outcome Treatment
    1