BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIDURAL CATHETERIZATION KIT: 19 GA

    MDR report key: 6179494 · Received December 15, 2016

    Report

    Report Number
    1036844-2016-00671
    Event Type
    Malfunction
    Date Received
    December 15, 2016
    Date of Event
    December 1, 2016
    Report Date
    December 5, 2016
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    CAZ
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    QN#(B)(4). NO LOT NUMBER WAS PROVIDED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED BASED UPON A LOT NUMBER FROM SALES HISTORY DATA. 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 (REFERENCE (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 BENT COMPARED TO A LAB INVENTORY NEEDLE. MICROSCOPIC EXAMINATION OF THE NEEDLE BEVEL REVEALED BIOLOGICAL MATERIAL CAN BE SEEN AT THE TIP AND 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 (REFERENCE (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 1.48MM (C05155), WHICH IS WITHIN SPECIFICATION OF 1.46MM-1.48MM PER GRAPHIC NZ-05500-003; REV 6. THE OTHER REMARKS: ID MEASURED 0.046IN (1.17MM) (C05157), WHICH IS WITHIN SPECIFICATION OF 1.17MM PER GRAPHIC KZ-05500-007; REV 7. AN ATTEMPT WAS MADE RECREATE THE OBSERVED DAMAGE USING A LAB INVENTORY NEEDLE. THE NEEDLE TIP WAS INSERTED INTO A STABLE MATERIAL AND THE NEEDLE HUB WAS TORQUED AT AN ANGLE IN ORDER TO RECREATE THE EVENT. THE OBSERVED RESULTS OF THE LAB INVENTORY WERE SIMILAR TO WHAT WAS OBSERVED IN THE RETURNED NEEDLE. SPECIFICATIONS PER GRAPHIC NZ-05500-003; REV 6 AND KZ-05500-007 REV. 7 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, OPERATIONAL CONTEXT CAUSED OR CONTRIBUTED TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION AT THIS TIME. THE MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    THE EPIDURAL NEEDLE BENT AND THE CATHETER COULD NOT BE THREADED. A NEW NEEDLE PUNCTURE WAS PERFORMED TO INSERT THE CATHETER. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

    Description of Event or Problem · 1

    THE EPIDURAL NEEDLE BENT AND THE CATHETER COULD NOT BE THREADED. A NEW NEEDLE PUNCTURE WAS PERFORMED TO INSERT THE CATHETER. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    827135 EPIDURAL CATHETERIZATION KIT: 19 GA ANESTHESIA CONDUCTION KIT CAZ ARROW INTERNATIONAL INC.

    Patients

    Seq Age Sex Outcome Treatment
    1