BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIDURAL CATHETERIZATION KIT

    MDR report key: 8709824 · Received June 18, 2019

    Report

    Report Number
    1036844-2019-00680
    Event Type
    Malfunction
    Date Received
    June 18, 2019
    Date of Event
    May 18, 2019
    Report Date
    May 22, 2019
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    BSO
    PMA / PMN Number
    K140110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE EPIDURAL NEEDLE AND EPIDURAL CATHETER WITH NO RELEVANT FINDINGS. THE CUSTOMER REPORTED THE EPIDURAL NEEDLE WAS DEFECTIVE. THE CUSTOMER RETURNED ONE EPIDURAL NEEDLE WITH STYLET AND LIDSTOCK (REFERENCE ATTACHED FILES INP1900069195). VISUAL EXAMINATION OF THE RETURNED NEEDLE REVEALED THE NEEDLE APPEARS TYPICAL. MICROSCOPIC EXAMINATION OF THE NEEDLE APPEARS USED AS BIOLOGICAL MATERIAL CAN BE SEEN IN THE BEVEL. ALSO, THE BEVEL REVEALED THE NEEDLE TIP IS BENT. THE NEEDLE BEVEL APPEARANCE IS SIMILAR TO A NEEDLE BEVEL THAT HAS BEEN PRESSED AGAINST A HARD SURFACE WITH FORCE. A DIMENSIONAL INSPECTION WAS PERFORMED ON THE RETURNED EPIDURAL NEEDLE. THE OUTER DIMENSION (OD) AND INNER DIMENSION (ID) OF THE RETURNED NEEDLE WAS MEASURED. THE OD OF THE RETURNED NEEDLE MEASURED 1.47MM (C05155), WHICH IS WITHIN SPECIFICATION OF 1.46MM-1.48MM PER GRAPHIC NZ-05500-003; REV 7. THE ID MEASURED 0.046IN (1.17MM) (C05157), 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 ONLY THREAD THROUGH THE NEEDLE'S TIP BASED ON THE TIP OF THE NEEDLE BEING BENT. SPECIFICATIONS PER GRAPHIC NZ-05500-003; REV 7 AND KZ-05500-007 REV. 9 WERE REVIEWED AS A PART OF THIS COMPLAINT INVESTIGATION. A REVIEW OF DESIGN CHANGE HISTORY FOR PART NUMBER NZ-05500-001 WAS PERFORMED AS A PART OF THIS INVESTIGATION. NO DESIGN CHANGES HAVE BEEN MADE TO THIS PRODUCT IN THE PAST TWO YEARS THAT WOULD HAVE LED TO THIS COMPLAINT. A CORRECTIVE ACTION IS NOT REQUIRED AT THIS TIME AS THE INVESTIGATION SHOWS NO EVIDENCE TO SUGGEST A MANUFACTURING RELATED CAUSE. THE DAMAGE WAS DISCOVERED DURING USE. THEREFORE, BASED ON THE CONDITION OF THE SAMPLE RECEIVED AND THE TIME OF DISCOVERY, UNINTENTIONAL USER ERROR CAUSED OR CONTRIBUTED TO THIS EVENT. A CORRECTIVE ACTION IS NOT REQUIRED AT THIS TIME AS THE INVESTIGATION SHOWS NO EVIDENCE TO SUGGEST A MANUFACTURING RELATED CAUSE. THE DAMAGE WAS DISCOVERED DURING USE. THEREFORE, BASED ON THE CONDITION OF THE SAMPLE RECEIVED AND THE TIME OF DISCOVERY, UNINTENTIONAL USER ERROR CAUSED OR CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ANESTHESIOLOGIST WAS USING A NEEDLE AND IT SEEMED TO FEEL DIFFERENT WHILE PLACING IT. IT WAS PLACED AND WAS UNABLE TO THREAD THE CATHETER. THE DOCTOR HAD TO PULL THE NEEDLE AND THE CATHETER OUT WHEN IT WAS NOTICED THAT THE TIP OF THE NEEDLE WAS DEFECTIVE. THERE WAS NO HARM TO THE PATIENT; A NEW KIT WAS USEDSUCCESSFULLY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE INVESTIGATION IS PENDING. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ANESTHESIOLOGIST WAS USING A NEEDLE AND IT SEEMED TO FEEL DIFFERENT WHILE PLACING IT. IT WAS PLACED AND WAS UNABLE TO THREAD THE CATHETER. THE DOCTOR HAD TO PULL THE NEEDLE AND THE CATHETER OUT WHEN IT WAS NOTICED THAT THE TIP OF THE NEEDLE WAS DEFECTIVE. THERE WAS NO HARM TO THE PATIENT; A NEW KIT WAS USED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501089 EPIDURAL CATHETERIZATION KIT ANESTHESIA CONDUCTION CATHETER BSO ARROW INTERNATIONAL INC. 23F19A0471

    Patients

    Seq Age Sex Outcome Treatment
    1 N/A.