BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIDURAL CATHETERIZATION SET

    MDR report key: 10733229 · Received October 26, 2020

    Report

    Report Number
    3006425876-2020-00895
    Event Type
    Malfunction
    Date Received
    October 26, 2020
    Date of Event
    September 30, 2020
    Report Date
    October 1, 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

    (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 OPENED KIT. THE EPIDURAL NEEDLE AND EPIDURAL CATHETER WERE REMOVED FROM THE KIT AND WERE VISUALLY EXAMINED WITH AND WITHOUT MAGNIFICATION. VISUAL EXAMINATION OF THE RETURNED NEEDLE REVEALED THAT THE NEEDLE APPEARS USED BUT TYPICAL. THE NEEDLE BEVEL APPEARS POLISHED AND SMOOTH WITH NO OBSERVED BURRS. THE NEEDLE CANNULA APPEARS TYPICAL. HOWEVER, THERE APPEARS TO BE SURGICAL TAPE ON THE CANNULA NEAR THE NEEDLE'S TIP. VISUAL EXAMINATION OF THE RETURNED CATHETER REVEALED THAT THE CATHETER APPEARS TYPICAL WITH NO DEFECTS OR ANOMALIES 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 (REF-003131), 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 1.05MM (CALIPER: REF-003210). HOWEVER, THE CATHETER'S DISTAL TIP MEASURED APPROXIMATELY 1.19MM (PIN GAUGES: REF-003131), WHICH IS 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 EPIDURAL CATHETER THROUGH THE RETURNED EPIDURAL NEEDLE. THE EPIDURAL CATHETER WAS THREAD AT THE DISTAL END AND WOULD NOT THREAD THROUGH THE EPIDURAL NEEDLE. THE TEST WAS REPEATED WITH THE RETURNED CATHETER AND A LAB INVENTORY NEEDLE WITH THE SAME RESULT. THE TEST WAS ONCE AGAIN REPEATED WITH THE RETURNED NEEDLE AND A LAB INVENTORY CATHETER WITH NO RESISTANCE MET. BASED ON THIS, A DRAG TEST COULD NOT BE PERFORMED. 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. THE RETURNED CATHETER WOULD NOT THREAD THROUGH THE RETURNED NEEDLE. THE TEST WAS REPEATED WITH THE RETURNED CATHETER AND A LAB INVENTORY NEEDLE WITH THE SAME RESULT. DIMENSIONAL INSPECTION OF THE RETURNED CATHETER REVEALED THE OD OF THE CATHETER BODY MEASURED APPROXIMATELY 1.05MM, HOWEVER, THE DISTAL TIP MEASURED APPROXIMATELY 1.19MM, WHICH IS 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 CATHETER'S OD BEING OUT OF SPECIFICATION, THE POTENTIAL ROOT CAUSE OF THIS COMPLAINT ISSUE IS MANUFACTURING RELATED. A NONCONFORMANCE HAS BEEN INITIATED TO FURTHER INVESTIGATE THIS ISSUE.

    Description of Event or Problem · 0

    REPORTED ISSUE: HAPPENED IN THE MATERNITY DEPARTMENT. DURING THE INSERTION OF THE EPIDURAL IT WAS IMPOSSIBLE TO ADVANCE THE CATHETER THROUGH THE TROCAR (NEEDLE) THAT WAS ALREADY INSERTED IN THE BACK OF THE PATIENT. THERE WAS NO CONSEQUENCE FOR THE FEMALE PATIENT. THE ISSUE WAS SOLVED BY USING ANOTHER KIT. THE CATHETER OF THE NEW KIT ADVANCED PROPERLY.

    Additional Manufacturer Narrative · 1

    QN#: (B)(4). THE DEVICE INVESTIGATION IS PENDING. TELEFLEX WILL CONTINUE TO MONITOR, AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    REPORTED ISSUE: HAPPENED IN THE MATERNITY DEPARTMENT. DURING THE INSERTION OF THE EPIDURAL IT WAS IMPOSSIBLE TO ADVANCE THE CATHETER THROUGH THE TROCAR (NEEDLE?) THAT WAS ALREADY INSERTED IN THE BACK OF THE PATIENT. THERE WAS NO CONSEQUENCE FOR THE FEMALE PATIENT. THE ISSUE WAS SOLVED BY USING ANOTHER KIT. THE CATHETER OF THE NEW KIT ADVANCED PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1198595 EPIDURAL CATHETERIZATION SET ANESTHESIA CONDUCTION KIT CAZ 71F20E2087

    Patients

    Seq Age Sex Outcome Treatment
    1 N/A.