BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIDURAL CATHETERIZATION KIT: 19 GA

    MDR report key: 6365846 · Received February 28, 2017

    Report

    Report Number
    1036844-2017-00058
    Event Type
    Malfunction
    Date Received
    February 28, 2017
    Date of Event
    January 31, 2017
    Report Date
    January 31, 2017
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    CAZ
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE INVESTIGATION HAS NOT BEEN SUBMITTED AT THIS TIME. THE MANUFACTURER 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 WITH STYLET, NEEDLE GUARD AND LIDSTOCK. THE RETURNED NEEDLE WAS VISUALLY EXAMINED WITH AND WITHOUT MAGNIFICATION. VISUAL EXAMINATION OF THE RETURNED NEEDLE REVEALED THE NEEDLE APPEARS TYPICAL. HOWEVER, MICROSCOPIC EXAMINATION OF THE NEEDLE BEVEL REVEALED THE NEEDLE IS SLIGHTLY BENT AT THE NEEDLE TIP. THE NEEDLE BEVEL APPEARANCE IS SIMILAR TO A NEEDLE BEVEL THAT HAS BEEN PRESSED AGAINST A HARD SURFACE WITH FORCE. THE CUSTOMER ALSO RETURNED A "UNDAMAGED" EPIDURAL NEEDLE. VISUAL EXAMINATION OF THE "UNDAMAGED" REVEALED THE NEEDLE IS TYPICAL WITH NO ANOMALIES OR DEFECTS OBSERVED. 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 OTHER REMARKS: WITHIN SPECIFICATION OF 1.17MM PER GRAPHIC KZ-05500-007; REV 8. SPECIFICATIONS PER GRAPHIC NZ-05500-003; REV 7 AND KZ-05500-007 REV. 8 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 # 72P16B0174 (VENDOR LOT # MM160201AJ). 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. THE REPORTED COMPLAINT OF THE NEEDLE BEING BENT DURING USE WAS CONFIRMED BASED ON THE SAMPLE RECEIVED. VISUAL EXAMINATION OF THE RETURNED NEEDLE REVEALED THE TIP OF THE NEEDLE BEVEL WAS SLIGHTLY 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. ALSO, 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, OPERATIONAL CONTEXT CAUSED OR CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    AS THE CLINICIAN WALKED THE NEEDLE OFF THE VERTEBRAE, HE USED SLIGHT FORWARD PRESSURE RESULTING IN THE NEEDLE TIP CURLING INWARD THUS PREVENTING CATHETER ADVANCEMENT. THE PROCEDURE HAD TO BE REPEATED. THE PATIENT'S CONDITION WAS REPORTED AS UNKNOWN.

    Description of Event or Problem · 1

    AS THE CLINICIAN WALKED THE NEEDLE OFF THE VERTEBRAE, HE USED SLIGHT FORWARD PRESSURE RESULTING IN THE NEEDLE TIP CURLING INWARD THUS PREVENTING CATHETER ADVANCEMENT. THE PROCEDURE HAD TO BE REPEATED. THE PATIENT'S CONDITION WAS REPORTED AS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149077 EPIDURAL CATHETERIZATION KIT: 19 GA ANESTHESIA CONDUCTION KIT CAZ ARROW INTERNATIONAL INC.

    Patients

    Seq Age Sex Outcome Treatment
    1