BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIDURAL CATHETERIZATION SET

    MDR report key: 8070832 · Received November 14, 2018

    Report

    Report Number
    3006425876-2018-00727
    Event Type
    Malfunction
    Date Received
    November 14, 2018
    Date of Event
    October 28, 2018
    Report Date
    October 31, 2018
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    BSO
    PMA / PMN Number
    K140110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE BATCH NUMBERS FROM NUEVO LAREDO COMPONENTS RELATED WITH THE BATCH 71F18H1863 ARE THE FOLLOWING: 74C1801333 (CA-000010-19),74D1802051(CA-000010-19), 74D1801888 (CA-000006-19), 74C1801849 (CA-000006-19), 74D1801887 (CA-000006-19). NO RELEVANT FINDINGS WERE FOUND DURING THE DHR REVIEW OF THESE BATCH. SUCH BATCH WERE MANUFACTURED ON MARCH AND APRIL OF 2018. A SAMPLE OF CATALOG NUMBER CA-000010-19 (SNAPLOCK ASSY) WAS RECEIVED FOR ANALYSIS. THE VISUAL INSPECTION WAS PERFORMED BEFORE THE FUNCTIONAL TEST AND IT CANNOT APPRECIATED THE ORIFICE WHERE THE CATHETER IS INTRODUCED. AFTER FUNCTIONAL TEST THE SAMPLE WAS BROKEN AND VISUALLY INSPECTED AGAIN AND WAS FOUND THE SOFT TUBE CA-000006-19 BENT NEAR TO CATHETER INSERTION COMPONENT TFX-000414. SAMPLE RECEIVED WAS COMPARED WITH CURRENT PRODUCTION. THE SAMPLE FAIL THE CATHETER INSERTION TEST (WI-002685 REV.03) EQUIPMENT NLC08827 NEITHER THE LEAK AND OCCLUSION TEST (TP-000031 REV.02) EQUIPMENT NLC09272. A NON-CONFORMANCE WAS OPENED IN ORDER TO ADDRESS SNAPLOCK OCCLUDED. SOME CORRECTIVE ACTIONS WERE PERFORMED. RE-WORK 100 % OF CURRENT MATERIAL WI-002292 WAS UPDATED WITH THE CORRECT ASSEMBLY THE SOFT TUBE AND CORRECT WAY TO PERFORM THE TEST TP-00031. VISUAL AID VA-0335 WAS CREATED TO SHOW THE CORRECT ASSEMBLY OF SOFT TUBE. PERSONNEL WAS RE-TRAINED ON THOSE CHANGES MATERIAL IS INSPECTED 100% FOR OCCLUSION. CUSTOMER COMPLAINT IS CONFIRMED BASED ON THE VISUAL INSPECTION. HOWEVER, A NON-CONFORMANCE WAS OPENED IN ORDER TO ADDRESS SNAPLOCK OCCLUDED. SOME CORRECTIVE ACTIONS WERE PERFORMED ON SEPTEMBER 2018.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING INSERTION, THE MEDICAL STAFF NOTICED THE END OF THE CATHETER WAS BLOCKED.

    Additional Manufacturer Narrative · 1

    (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

    IT WAS REPORTED THAT DURING INSERTION, THE MEDICAL STAFF NOTICED THE END OF THE CATHETER WAS BLOCKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    911241 EPIDURAL CATHETERIZATION SET ANESTHESIA CONDUCTION CATHETER BSO ARROW INTERNATIONAL INC. 71F18H1863

    Patients

    Seq Age Sex Outcome Treatment
    1