BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIDURAL CATHETERIZATION SET

    MDR report key: 10697688 · Received October 19, 2020

    Report

    Report Number
    3006425876-2020-00914
    Event Type
    Malfunction
    Date Received
    October 19, 2020
    Date of Event
    October 7, 2020
    Report Date
    October 7, 2020
    Product Code
    CAZ
    PMA / PMN Number
    K103658
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4). A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE EPIDURAL CATHETER AND EPIDURAL NEEDLE WITH NO RELEVANT FINDINGS. THE CUSTOMER REPORTED THE CATHETER WOULD NOT THREAD THROUGH THE EPIDURAL NEEDLE. THE CUSTOMER RETURNED ONE EPIDURAL NEEDLE, ONE EPIDURAL CATHETER, AND LIDSTOCK. THE COMPONENTS WERE VISUALLY EXAMINED WITH AND WITHOUT MAGNIFICATION. VISUAL EXAMINATION OF THE RETURNED NEEDLE REVEALED THE NEEDLE APPEARS TYPICAL. THE NEEDLE BEVEL APPEARS POLISHED AND SMOOTH WITH NO OBSERVED BURRS. THE NEEDLE CANNULA APPEARS TYPICAL WITH NO DEFECTS OR ANOMALIES OBSERVED. VISUAL EXAMINATION OF THE RETURNED CATHETER REVEALED THE CATHETER APPEARS TYPICAL WITH NO ANOMALIES OR DEFECTS WERE OBSERVED. A DIMENSIONAL INSPECTION WAS PERFORMED ON THE RETURNED EPIDURAL NEEDLE. INNER DIAMETER (ID) MEASUREMENT OF THE RETURNED NEEDLE REVEALED A VALUE OF 0.046"/1.168MM USING PIN GAUGES (B)(4), WHICH IS WITHIN SPECIFICATION (1.15MM + 0.02MM) PER GRAPHIC KZ-80810-001, REV 2. A DIMENSIONAL INSPECTION WAS PERFORMED ON THE RETURNED EPIDURAL CATHETER. THE OUTER DIAMETER (OD) OF THE RETURNED CATHETER MEASURED 1.06MM (CALIPER: (B)(4)). HOWEVER, THE CATHETER'S DISTAL TIP MEASURED APPROXIMATELY 1.12MM (PIN GAUGES: (B)(4) ), WHICH IS SLIGHTLY OUTSIDE THE SPECIFICATION OF A MAXIMUM OF 1.115MM PER GRAPHIC KZ-05400-021; REV 4. A FUNCTIONAL TEST WAS PERFORMED BY ATTEMPTING TO THREAD THE RETURNED CATHETER THROUGH THE RETURNED EPIDURAL NEEDLE. THE CATHETER CAN BE INSERTED INTO THE NEEDLE'S CANNULA WITH NO RESISTANCE UNTIL THE CATHETER'S DISTAL TIP REACHES THE NEEDLE'S CANNULA TIP. WITH SOME FORCE, THE CATHETER PASSES THROUGH THE NEEDLE'S TIP AND NO RESISTANCE MET AFTER INITIAL INSERTION IS BEYOND THE CATHETER'S TIP. A DRAG TEST WAS PERFORMED PER PIP-013, REV 3 USING THE RETURNED COMPONENTS AND A WEIGHT (B)(4). THE CATHETER COULD THREAD THROUGH THE RETURNED NEEDLE WITH NO RESISTANCE MET AFTER THE INITIAL INSERTION BEYOND THE CATHETER'S DISTAL TIP. THE RETURNED SAMPLE WAS SENT TO THE MANUFACTURING SITE (HRADEC) FOR FURTHER ANALYSIS. ACCORDING TO THE MANUFACTURING SITE, THE RETURNED CATHETER WAS WITHIN SPECIFICATION BASED ON THEIR MEASUREMENTS. HOWEVER, THE MANUFACTURING SITE REVEALED THE ANGLE CUT AT THE RETURNED NEEDLE'S CANNULA TIP MEASURED 10 05", WHICH WAS OUT OF SPECIFICATION OF MAXIMUM OF 10 00" PER THE VENDORS SPECIFICATIONS, WHICH CAN CAUSE ISSUES THREADING THE CATHETER THROUGH THE NEEDLE. THE NEEDLE IS A PURCHASED PART THROUGH THE ZDAR FACILITY. SPECIFICATIONS PER GRAPHIC KZ-80810-001, REV 2 AND KZ-05400-021; REV 4 WERE REVIEWED AS A PART OF THIS COMPLAINT INVESTIGATION. A DESIGN HISTORY REVIEW WAS PERFORMED FOR PART # KZ-80810-001 AND KZ-05400-021 AS A PART OF THIS COMPLAINT INVESTIGATION. THERE HAVE BEEN NO MATERIAL CHANGES FOR THESE PARTS DURING THE LAST TWO YEARS THAT COULD HAVE LED TO THIS COMPLAINT. A NONCONFORMANCE HAS BEEN INITIATED TO FURTHER INVESTIGATE THIS COMPLAINT ISSUE. THE REPORTED COMPLAINT OF THE CATHETER NOT THREADING THROUGH THE NEEDLE WAS CONFIRMED BASED ON THE SAMPLE RECEIVED. FUNCTIONAL TESTING REVEALED THE CATHETER WOULD THREAD THROUGH THE NEEDLE'S CANNULA; HOWEVER, RESISTANCE WAS MET WHEN THE CATHETER'S DISTAL TIP WOULD REACH THE CANNULA TIP. AFTER THE INITIAL INSERTION BEYOND THE CATHETER'S DISTAL TIP, NO RESISTANCE WAS MET THREADING THROUGH THE CANNULA. THE RETURNED SAMPLE WAS SENT TO THE MANUFACTURING SITE WHERE IT WAS REVEALED THE ANGLE CUT AT THE RETURNED NEEDLE'S CANNULA TIP WAS SLIGHTLY OUT OF SPECIFICATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE EPIDURAL CATHETER AND EPIDURAL NEEDLE WITH NO RELEVANT FINDINGS. HOWEVER, BASED ON THE MANUFACTURING SITE'S ANALYSIS, THE POTENTIAL ROOT CAUSE OF THIS COMPLAINT ISSUE IS SUPPLIER RELATED. A NONCONFORMANCE HAS BEEN INITIATED TO FURTHER INVESTIGATE THIS ISSUE.

    Description of Event or Problem · 0

    ISSUE REPORTED: THE CATHETER WAS TIGHT IN THE NEEDLE AND COULD NOT ADVANCE. THE DOCTOR REMOVED THE NEEDLE AND STARTED ALL OF THE PROCESS AGAIN. ADDITIONAL INFORMATION: THE CONSEQUENCE FOR THE PATIENT WAS THAT IT NEEDED A NEW INSERTION OF A NEEDLE. IT WAS ANNOYING BUT NOT AN ISSUE AND THERE WERE NO CONSEQUENCES.

    Additional Manufacturer Narrative · 1

    QN#: (B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. TELEFLEX WILL CONTINUE TO MONITOR, AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    ISSUE REPORTED: THE CATHETER WAS TIGHT IN THE NEEDLE, AND COULD NOT ADVANCE. THE DOCTOR REMOVED THE NEEDLE, AND STARTED ALL OF THE PROCESS AGAIN. ADDITIONAL INFORMATION: THE CONSEQUENCE FOR THE PATIENT WAS THAT IT NEEDED A NEW INSERTION OF A NEEDLE. IT WAS ANNOYING, BUT NOT AN ISSUE, AND THERE WERE NO CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1161846 EPIDURAL CATHETERIZATION SET ANESTHESIA CONDUCTION KIT CAZ IPN046313 71F20H2475

    Patients

    Seq Age Sex Outcome Treatment
    1