BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE LUMEN POLYETHYLENE CENTRAL VENOUS CATHETER TRAY

    MDR report key: 9830940 · Received March 13, 2020

    Report

    Report Number
    1820334-2020-00606
    Event Type
    Malfunction
    Date Received
    March 13, 2020
    Date of Event
    September 17, 2019
    Report Date
    March 13, 2020
    Manufacturer
    COOK INC
    Product Code
    DQY
    UDI-DI
    00827002028548
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OCCUPATION: VALUE ANALYSIS COORDINATOR. PMA/510(K) #: PREAMENDMENT. (B)(4). INVESTIGATION - EVALUATION: (B)(6) HOSPITAL (UNITED STATES) INFORMED COOK OF AN INCIDENT ON (B)(6) 2019 INVOLVING TWO NEEDLES IN C-PMSY-250 (SINGLE LUMEN POLYETHYLENE CENTRAL VENOUS CATHETER TRAY) TRAYS FROM LOT 9864806. THE CUSTOMER STATED THAT WHILE PLACING A PERIPHERAL ARTERIAL LINE IN A 2.5KG PATIENT, THEY WERE UNABLE TO GET BLOOD RETURN DESPITE CONFIRMING WITH ULTRASOUND THAT THE NEEDLE WAS IN THE ARTERY. THE USER ATTEMPTED TO INSERT THE WIRE, BUT WAS UNABLE. THEY REPLACED THE NEEDLE WITH ANOTHER NEEDLE FROM THE SAME LOT, AND HAD THE SAME ISSUE. THEY WERE EVENTUALLY ABLE TO ADVANCE THE WIRE THROUGH THE SECOND NEEDLE AND INTO THE PATIENT WITH DIFFICULTY. A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), AND QUALITY CONTROL, AS WELL AS A FUNCTIONAL TEST AND VISUAL INSPECTION OF THE RETURNED DEVICE, AS WELL AS AN INSPECTION OF UNUSED PRODUCT, WAS CONDUCTED DURING THE INVESTIGATION. ONE USED NEEDLE, AN OPENED TRAY, AND 5 UNOPENED TRAYS WERE RETURNED TO COOK FOR EVALUATION. UPON FUNCTIONAL TEST, THE USED WIRE WAS ADVANCED THROUGH ALL OF THE NEEDLES SUCCESSFULLY WITHOUT DIFFICULTY. VISUAL INSPECTION FOUND NO DAMAGE ON ANY OF THE DEVICES. THIS ANALYSIS CONCLUDED THAT THERE IS NO EVIDENCE THESE DEVICES WERE MANUFACTURED OUT OF SPECIFICATION. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. THE DEVICE MASTER RECORD (DMR) FOUND THAT PROPER PROCEDURES AND INSPECTIONS ARE IN PLACE TO PREVENT THE DISTRIBUTION OF NON-CONFORMING PRODUCT. A REVIEW OF THE DEVICE'S DESIGN HISTORY FILES FOUND THAT THE PRODUCT IS BOTH SAFE AND EFFECTIVE FOR ITS INTENDED USE. A REVIEW OF THE DHRS FOR THE REPORTED COMPLAINT DEVICE LOT (9864806) AND THE RELATED NEEDLE COMPONENT SUB-ASSEMBLY LOT (IC9732187) REVEALED NO NON-CONFORMANCES. HOWEVER, A DATABASE REVIEW REVEALED SIX OTHER EVENTS RELATED TO THIS FAILURE MODE. AS THE NEEDLE IS SUPPLIED BY COOK POLYMER TECHNOLOGY (CPT), COOK INITIATED A SUPPLIER CORRECTIVE ACTION REQUEST IN RESPONSE TO THIS ISSUE. AS THERE IS EVIDENCE OF POTENTIALLY NONCONFORMING MATERIAL FROM THE SAME SUPPLIER LOTS IN OTHER EVENTS, COOK INITIATED PRODUCT CONTAINMENT FOR AFFECTED IN HOUSE PRODUCT AND TO PREVENT REDISTRIBUTION OF PRODUCT IN THE FIELD. COOK ALSO REVIEWED PRODUCT LABELING. THE INSTRUCTIONS FOR USE [IFU_T_ULMBH_REV5] STATE "UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED." BASED ON THE INFORMATION PROVIDED, EVALUATION OF THE RETURNED PRODUCT, AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE WAS ESTABLISHED AS A DEFICIENCY IN SUPPLIER MANUFACTURING/QUALITY CONTROL. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. A FIELD ACTION RESPONSE WAS INITIATED BUT DETERMINED THAT NO ACTION IS WARRANTED AT THIS TIME. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE WIRE GUIDE WOULD NOT PASS THROUGH THE NEEDLE INCLUDED IN A SINGLE LUMEN POLYETHYLENE CENTRAL VENOUS CATHETER TRAY. WHILE PLACING A PERIPHERAL ARTERIAL LINE, THE PHYSICIAN WAS UNABLE TO GET BLOOD RETURN DESPITE USING AN ULTRASOUND FOR VISUAL AID. AT THIS POINT, THE PHYSICIAN COULD NOT ADVANCE THE WIRE GUIDE THROUGH THE NEEDLE TO COMPLETE THE PROCEDURE. AFTER "A COUPLE OF ATTEMPTS", THE PHYSICIAN OBTAINED A SECOND KIT. UNFORTUNATELY, THE PHYSICIAN RAN INTO THE SAME ISSUE. EVENTUALLY, THE PHYSICIAN WAS ABLE TO GET THE WIRE THROUGH THE NEEDLE "WITH SOME DIFFICULTY" BUT "FELT A POP" RIGHT BEFORE. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295361 SINGLE LUMEN POLYETHYLENE CENTRAL VENOUS CATHETER TRAY DQY CATHETER, PERCUTANEOUS DQY COOK INC G02854 9864806 00827002028548

    Patients

    Seq Age Sex Outcome Treatment
    1