BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIDURAL CATHETERIZATION SET

    MDR report key: 10288473 · Received July 17, 2020

    Report

    Report Number
    3011137372-2020-00149
    Event Type
    Malfunction
    Date Received
    July 17, 2020
    Date of Event
    June 24, 2020
    Report Date
    June 24, 2020
    Product Code
    CAZ
    PMA / PMN Number
    K103658
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4). A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE EPIDURAL NEEDLE WITH NO RELEVANT FINDINGS. THE CUSTOMER REPORTED THAT THE EPIDURAL NEEDLE TIP WAS BENT. THE CUSTOMER RETURNED ONE EMPTY KIT WITH AN EPIDURAL NEEDLE AND EPIDURAL CATHETER. THE SAMPLE WAS RECEIVED WITH THE CATHETER INSERTED INTO THE NEEDLE (REFERENCE ATTACHED FILES INP1900077727). THE RETURNED SAMPLE WAS VISUALLY EXAMINED WITH AND WITHOUT MAGNIFICATION. VISUAL EXAMINATION OF THE RETURNED NEEDLE REVEALED THE NEEDLE APPEARS USED. THE CANNULA OF THE RETURNED NEEDLE IS SLIGHTLY BENT. MICROSCOPIC EXAMINATION OF THE NEEDLE BEVEL REVEALED BIOLOGICAL MATERIAL CAN BE SEEN ON THE NEEDLE'S BEVEL. ALSO, THE NEEDLE'S TIP IS BENT. THE NEEDLE BEVEL APPEARANCE IS SIMILAR TO A NEEDLE BEVEL THAT HAS BEEN PRESSED AGAINST A HARD SURFACE WITH FORCE (REFERENCE ATTACHED FILES ANP1900077727). VISUAL EXAMINATION OF THE RETURNED CATHETER REVEALED THAT THE CATHETER APPEARS TYPICAL, BUT USED. BIOLOGICAL MATERIAL CAN BE SEEN ON THE INNER COIL WIRE AND ADHESIVE MATERIAL CAN BE SEEN ON THE OUTER EXTRUSION. NO OTHER DEFECTS OR ANOMALIES WERE OBSERVED. A DIMENSIONAL INSPECTION WAS PERFORMED ON THE RETURNED EPIDURAL NEEDLE. THE ID MEASURED 0.046IN (1.17MM) (PIN GAUGE: REF-003131), WHICH IS WITHIN SPECIFICATION OF 1.17MM PER GRAPHIC KZ-05500-007; REV 9. A DIMENSIONAL INSPECTION WAS PERFORMED ON THE RETURNED EPIDURAL CATHETER. THE OUTER DIAMETER (OD) OF THE RETURNED CATHETER MEASURED 1.08MM (CALIPER: REF-003210) WHICH IS WITHIN THE SPECIFICATION OF A MAXIMUM OF 1.115MM PER GRAPHIC KZ-05400-021; REV 4. SPECIFICATIONS PER GRAPHIC KZ-05500-007, REV 9 WAS REVIEWED AS A PART OF THIS COMPLAINT INVESTIGATION. A DESIGN HISTORY REVIEW WAS PERFORMED FOR PART # KZ-05500-007 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 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. THE REPORTED COMPLAINT OF THE NEEDLE TIP BEING BENT WAS CONFIRMED BASED ON THE SAMPLE RECEIVED. VISUAL EXAMINATION OF THE RETURNED NEEDLE REVEALED THE CANNULA WAS SLIGHTLY BENT. ALSO, THE TIP OF THE NEEDLE BEVEL WAS BENT, WHICH IS CONSISTENT WITH DAMAGE THAT CAN BE CAUSED WHEN A NEEDLE BEVEL IS PRESSED AGAINST A HARD SURFACE. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE EPIDURAL NEEDLE WITH NO RELEVANT FINDINGS. NO MATERIAL ISSUES WERE FOUND FROM THE VENDOR FOR THE CANNULA. THEREFORE, BASED UPON THE INFORMATION PROVIDED, THE OBSERVED NEEDLE DAMAGE, AND THE TIME OF DISCOVERY, UNINTENTIONAL USER ERROR CAUSED OR CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 0

    THE REPORT STATES: DIRECT FROM 3S0 COMPLAINT FORM THE TOUHY IN THE KIT WAS BENT OR PINCHED AT THE TIP, THEREFORE THE CATHETER COULD NOT BE THREAD THROUGH. PRIOR TO USE PRETESTING.

    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

    THE REPORT STATES: DIRECT FROM 3S0 COMPLAINT FORM THE TOUHY IN THE KIT WAS BENT OR PINCHED AT THE TIP, THEREFORE THE CATHETER COULD NOT BE THREAD THROUGH. PRIOR TO USE PRETESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752092 EPIDURAL CATHETERIZATION SET ANESTHESIA CONDUCTION KIT CAZ 13F20D186

    Patients

    Seq Age Sex Outcome Treatment
    1