BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIDURAL NEEDLE COMPONENT

    MDR report key: 6830189 · Received August 30, 2017

    Report

    Report Number
    1036844-2017-00332
    Event Type
    Malfunction
    Date Received
    August 30, 2017
    Date of Event
    March 13, 2017
    Report Date
    August 15, 2017
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    CAZ
    PMA / PMN Number
    K103658
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE INVESTIGATION REPORT HAS NOT BEEN SUBMITTED AT THIS TIME. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Additional Manufacturer Narrative · 1

    (B)(4). A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE EPIDURAL NEEDLE WITH NO RELEVANT FINDINGS. THE CUSTOMER REPORTED THE EPIDURAL NEEDLE BENT DURING USE. THE CUSTOMER RETURNED ONE EPIDURAL NEEDLE AND PACKAGING. THE RETURNED NEEDLE 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 BENT. MICROSCOPIC EXAMINATION OF THE NEEDLE BEVEL REVEALED BIOLOGICAL MATERIAL CAN BE SEEN ON THE NEEDLE'S BEVEL. THE NEEDLE'S TIP IS ALSO SLIGHTLY 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 DIMENSIONAL INSPECTION WAS PERFORMED ON THE RETURNED EPIDURAL NEEDLE. THE OUTER DIMENSION (OD) AND INNER DIMENSION. 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. ADDITIONAL TESTING OF THE NEEDLE TIPS WAS PERFORMED BY THE MANUFACTURING SITE TO DETERMINE TIP STRENGTH. TESTING WAS PERFORMED TO COMPARE NEEDLE TIPS STRENGTHS FROM FIVE AVAILABLE SETS OF DIFFERENT NEEDLES. THE TEST CONCLUDED THAT THE NEEDLE SETS HAD VERY SIMILAR RESULTS. 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 REVIEW OF THE QUALITY INSPECTION REPORT FROM THE VENDOR OF THE CANNULA (NZ-05500-001) FOUND NO MATERIAL ISSUES FOR LOT # 72P15M0007 (VENDOR LOT # MM151105AJ). 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, OPERATIONAL CONTEXT CAUSED OR CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    THE NEEDLES ARE BENDING. THERE WAS NO PATIENT INJURY.

    Description of Event or Problem · 1

    THE NEEDLES ARE BENDING. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612800 EPIDURAL NEEDLE COMPONENT ANESTHESIA CONDUCTION KIT CAZ ARROW INTERNATIONAL INC. 13F16E0090

    Patients

    Seq Age Sex Outcome Treatment
    1