BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIDURAL CATHETERIZATION KIT

    MDR report key: 6277366 · Received January 25, 2017

    Report

    Report Number
    1036844-2017-00039
    Event Type
    Malfunction
    Date Received
    January 25, 2017
    Date of Event
    January 3, 2017
    Report Date
    January 9, 2017
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    CAZ
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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 (REFERENCE ATTACHED FILES (B)(4)). 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 (REFERENCE FILES (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 ((B)(4)), WHICH IS WITHIN SPECIFICATION OF 1.46MM-1.48MM PER GRAPHIC (B)(4); REV 6. THE ID MEASURED 0.046IN (1.17MM) ((B)(4)), WHICH IS WITHIN SPECIFICATION OF 1.17MM PER GRAPHIC OTHER REMARKS: KZ-05500-007; REV 7. 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. 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. 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

    THE DEVICE BENT AT THE TIP. IT LOOKS LIKE THE DISTAL TIP CURLED BACK PERMANENTLY DAMAGING THE NEEDLE. THE PROCEDURE WAS REPEATED. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

    Description of Event or Problem · 1

    THE DEVICE BENT AT THE TIP. IT LOOKS LIKE THE DISTAL TIP CURLED BACK PERMANENTLY DAMAGING THE NEEDLE. THE PROCEDURE WAS REPEATED. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58547 EPIDURAL CATHETERIZATION KIT ANESTHESIA CONDUCTION KIT CAZ ARROW INTERNATIONAL INC. 23F16J0801

    Patients

    Seq Age Sex Outcome Treatment
    1