BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIDURAL CATHETERIZATION KIT: 19 GA

    MDR report key: 6498684 · Received April 17, 2017

    Report

    Report Number
    1036844-2017-00149
    Event Type
    Malfunction
    Date Received
    April 17, 2017
    Date of Event
    March 21, 2017
    Report Date
    March 21, 2017
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    CAZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    QN#(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

    QN#(B)(4). A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE EPIDURAL NEEDLE WITH NO RELEVANT FINDINGS. THE CUSTOMER REPORTED THE EPIDURAL NEEDLE TIP BENT DURING USE. THE CUSTOMER RETURNED ONE EPIDURAL NEEDLE ((B)(4)). 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 SLIGHTLY BENT. MICROSCOPIC EXAMINATION OF THE NEEDLE BEVEL REVEALED THE NEEDLE 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 ((B)(4)). 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 OTHER REMARKS: KZ-05500-007; REV 8. 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 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 # 72P15J0017 (VENDOR LOT # MM150805AJ). 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 TIP BENDING DURING USE WAS CONFIRMED BASED ON THE SAMPLE RECEIVED. VISUAL EXAMINATION OF THE RE TURNED NEEDLE REVEALED THE CANNULA AND TIP OF THE NEEDLE BEVEL WERE SLIGHTLY BENT, WHICH IS CONSISTENT WITH DAMAGE THAT CAN BE CAUSED WHEN A NEEDLE BEVEL IS PRESSED AGAINST A HARD SURFACE AND TORQUED. AN ATTEMPT TO RECREATE THE EVENT WAS PERFORMED USING A LAB INVENTORY NEEDLE OF THE SAME KIND. THE BEND IN THE LAB INVENTORY NEEDLE HAD SIMILAR RESULTS AS THE RETURNED NEEDLE. 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. ALSO, A NEEDLE TIP STRENGTH STUDY WAS PERFORMED BY THE MANUFACTURING SITE WHICH REVEALED VERY SIMILAR RESULTS WITH FIVE DIFFERENT SETS OF NEEDLES. 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

    IT WAS REPORTED THAT THE NEEDLE TIP WAS BENDING UPON INSERTION OF EPIDURAL NEEDLE. ANOTHER NEEDLE PUNCTURE WAS REQUIRED. THE PATIENT'S CONDITION WAS REPORTED AS UNKNOWN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLE TIP WAS BENDING UPON INSERTION OF EPIDURAL NEEDLE. ANOTHER NEEDLE PUNCTURE WAS REQUIRED. THE PATIENT'S CONDITION WAS REPORTED AS UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279579 EPIDURAL CATHETERIZATION KIT: 19 GA ANESTHESIA CONDUCTION KIT CAZ ARROW INTERNATIONAL INC. 23F16K0653

    Patients

    Seq Age Sex Outcome Treatment
    1