BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIDURAL CATHETERIZATION KIT

    MDR report key: 14116123 · Received April 14, 2022

    Report

    Report Number
    1036844-2022-00026
    Event Type
    Malfunction
    Date Received
    April 14, 2022
    Date of Event
    April 4, 2022
    Report Date
    April 4, 2022
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    BSO
    UDI-DI
    50801902012055
    PMA / PMN Number
    K140110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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, STYLET, AND EPIDURAL NEEDLE WITH NO RELEVANT FINDINGS. THE CUSTOMER REPORTED THE CATHETER KINKED WHEN THREADING. THE CUSTOMER RETURNED AN EPIDURAL CATHETER WITH STYLET AND LIDSTOCK (REFERENCE ATTACHED FILES INP1900092145). THE RETURNED SAMPLE 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. VISUAL EXAMINATION OF THE RETURNED STYLET REVEALED THE STYLET APPEARS TO BE BENT AT APPROXIMATELY 30MM (RULER: REF-003192) FROM THE DISTAL END. NO OTHER DEFECTS OR ANOMALIES WERE OBSERVED. A DIMENSIONAL INSPECTION WAS PERFORMED ON THE RETURNED EPIDURAL. THE OUTER DIAMETER (OD) OF THE RETURNED CATHETER MEASURED 1.04MM (CALIPER: REF-003210) 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 AND REMOVE THE RETURNED STYLET FROM THE RETURNED CATHETER. THE RETURNED STYLET COULD BE FULLY THREADED AND REMOVED FROM THE RETURNED CATHETER, BUT WITH SOME RESISTANCE BASED ON THE BEND IN THE RETURNED STYLET. THE SAME TEST WAS PERFORMED WITH A LAB INVENTORY STYLET AND THE RETURNED CATHETER WITH NO ISSUES. A FUNCTIONAL TEST WAS ALSO 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 PASSED THE DRAG TEST. SPECIFICATIONS PER GRAPHIC KZ-05400-030; REV 5 WERE REVIEWED AS A PART OF THIS COMPLAINT INVESTIGATION. A DESIGN HISTORY REVIEW WAS PERFORMED FOR PART KZ-05400-030 AND S-05501-002 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 OF THE CATHETER KINKED WHEN THREADING WAS CONFIRMED BASED ON THE SAMPLE RECEIVED. VISUAL EXAMINATION OF THE R ETURNED STYLET REVEALED THE STYLET WAS BENT NEAR THE DISTAL END. FUNCTIONAL TESTING PERFORMED ON THE RETURNED SAMPLE REVEALED THE STYLET COULD BE REMOVED AND FULLY INSERTED INTO THE CATHETER, BUT WITH SOME RESISTANCE BASED ON THE BENT STYLET. SIMILAR TESTING PERFORMED WITH A LAB INVENTORY STYLET AND THE RETURNED CATHETER INDICATED NO ISSUES INSERTING OR REMOVING FROM THE CATHETER. 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, STYLET AND EPIDURAL NEEDLE WITH NO RELEVANT FINDINGS. IT IS UNKNOWN HOW THE CATHETER/STYLET WAS HANDLED PRIOR TO AND DURING USE. THE INVESTIGATION FOUND NO EVIDENCE TO SUGGEST A MANUFACTURING RELATED CAUSE. THEREFORE, THE POTENTIAL CAUSE OF THIS COMPLAINT COULD NOT BE DETERMINED. NO FURTHER ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    WHEN PHYSICIAN WAS THREADING THE CATHETER IT KINKED. HE THINKS THAT MIGHT BE WHY THE EPIDURAL BLOCK DID NOT WORK WELL.

    Description of Event or Problem · 0

    WHEN PHYSICIAN WAS THREADING THE CATHETER IT KINKED. HE THINKS THAT MIGHT BE WHY THE EPIDURAL BLOCK DID NOT WORK WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138052 EPIDURAL CATHETERIZATION KIT ANESTHESIA CONDUCTION CATHETER BSO ARROW INTERNATIONAL LLC IPN046485 23F21L0186 50801902012055

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown