BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIDURAL CATHETERIZATION KIT NRFIT

    MDR report key: 12519885 · Received September 23, 2021

    Report

    Report Number
    3006425876-2021-00885
    Event Type
    Malfunction
    Date Received
    September 23, 2021
    Date of Event
    September 2, 2021
    Report Date
    September 3, 2021
    Product Code
    OFT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE CUSTOMER REPORTED THE CATHETER WOULD NOT THREAD THROUGH THE EPIDURAL NEEDLE. THE CUSTOMER RETURNED ONE OPENED KIT. THE EPIDURAL CATHETER AND NEEDLE WERE REMOVED AND VISUALLY EXAMINED WITH AND WITHOUT MAGNIFICATION. VISUAL EXAMINATION OF THE RETURNED EPIDURAL NEEDLE REVEALED THE NEEDLE IS TYPICAL WITH NO DEFECTS OR ANOMALIES OBSERVED. 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 NEEDLE. THE INNER DIAMETER (ID) MEASURED 0.046IN (1.17MM) (PIN GAUGE: REF-003131). 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 THE RETURNED CATHETER THROUGH THE RETURNED 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 COMPONENTS AND A WEIGHT (REF-002579). THE CATHETER COULD THREAD THROUGH THE RETURNED NEEDLE WITH NO RESISTANCE MET. THE COMPONENTS PASSED THE DRAG TEST. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE EPIDURAL CATHETER WITH NO RELEVANT FINDINGS. A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED ON THE EPIDURAL NEEDLE AS ACCORDING TO THE BILL OF MATERIAL (BOM) FOR REPORTED KIT OU-05500-NRON, AN EPIDURAL NEEDLE IS NOT PACKAGED WITH THE REPORTED KIT. 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 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 THERE WERE NO FUNCTIONAL ISSUES FOUND WITH THE RETURNED SAMPLE. THE REPORTED COMPLAINT OF THE CATHETER UNABLE TO THREAD COULD NOT BE CONFIRMED BASED ON THE SAMPLE RECEIVED. THE RETURNED CATHETER COULD BE THREADED THROUGH THE RETURNED NEEDLE WITH NO RESISTANCE MET. THE RETURNED COMPONENTS 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 WITH NO RELEVANT FINDINGS. A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED ON THE EPIDURAL NEEDLE AS ACCORDING TO THE BILL OF MATERIAL (BOM) FOR REPORTED KIT OU-05500-NRON, AN EPIDURAL NEEDLE IS NOT PACKAGED WITH THE REPORTED KIT. BASED ON THIS, THERE WERE NO FUNCTIONAL ISSUES FOUND WITH THE RETURNED SAMPLE. NO FURTHER ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE USER WAS UNABLE TO INSERT THE CATHETER INTO THE EPIDURAL NEEDLE BECAUSE OF RESISTANCE DURING USE. THEREFORE, A NEW KIT WAS USED INSTEAD.

    Additional Manufacturer Narrative · 1

    QN# (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 USER WAS UNABLE TO INSERT THE CATHETER INTO THE EPIDURAL NEEDLE BECAUSE OF RESISTANCE DURING USE. THEREFORE, A NEW KIT WAS USED INSTEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1421545 EPIDURAL CATHETERIZATION KIT NRFIT OFT 71F20H3119

    Patients

    Seq Age Sex Outcome Treatment
    1