BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE LUMEN PRESSURE MONITORING SET

    MDR report key: 9959019 · Received April 14, 2020

    Report

    Report Number
    1820334-2020-00812
    Event Type
    Malfunction
    Date Received
    April 14, 2020
    Date of Event
    October 15, 2019
    Report Date
    April 14, 2020
    Manufacturer
    COOK INC
    Product Code
    DQY
    UDI-DI
    00827002028388
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OCCUPATION: UNKNOWN. PMA/510(K) #: PREAMENDMENT. INVESTIGATION - EVALUATION: A CUSTOMER AT VIRGINIA COMMONWEALTH UNIVERSITY HEALTH SYSTEM (UNITED STATES) REPORTED THAT TWO NEEDLES IN C-PMS-250 (SINGLE LUMEN PRESSURE MONITORING SET) SETS FROM LOT 9961061 WERE OCCLUDED DURING AN ARTERIAL LINE PLACEMENT ON (B)(6) 2019. THE CUSTOMER STATED THAT THEY WERE NOT ABLE TO PASS A WIRE GUIDE THROUGH THE NEEDLE ONCE IT WAS INSERTED INTO THE PATIENT. THE PATIENT DID NOT EXPERIENCE ADVERSE EFFECTS. A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), INSTRUCTIONS FOR USE (IFU) AND QUALITY CONTROL OF THE DEVICE, AS WELL AS A VISUAL INSPECTION AND FUNCTIONAL TEST OF UNUSED PRODUCT RETURNED BY THE USER WAS CONDUCTED DURING THE INVESTIGATION. THOUGHT THE COMPLAINT DEVICES WERE NOT RETURNED, THE USER FACILITY RETURNED THREE UNOPENED DEVICES FROM THE SAME LOT AS THE COMPLAINT DEVICES. VISUAL INSPECTION OF THE DEVICES REVEALED NO VISIBLE DAMAGE OR ABNORMALITIES. THE WIRES FOR EACH SET WERE INSERTED THROUGH THE NEEDLES PROXIMALLY AND DISTALLY WITHOUT ANY RESISTANCE. NOTHING EXITED THE LUMENS OF THE NEEDLES. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. THE DEVICE MASTER RECORD (DMR) CONCLUDED 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 (9961061) AND THE RELATED NEEDLE COMPONENT LOT REVEALED NO RECORDED NON-CONFORMANCES. A DATABASE SEARCH FOUND ONE ADDITIONAL COMPLAINT (MFG. REPORT REFERENCE #:1820334-2020-00802) FOR THE SAME FAILURE MODE WITH DEVICES FROM THE SAME LOT. HOWEVER, BASED ON THE DHR REVIEW, THERE IS EVIDENCE OF POTENTIAL NONCONFORMING MATERIAL IN HOUSE AND IN FIELD. 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 STATE "UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED." BASED ON THE INFORMATION PROVIDED, EXAMINATION OF UNUSED 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. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A WIRE GUIDE WOULD NOT PASS THROUGH THE NEEDLES INCLUDED IN TWO SINGLE LUMEN PRESSURE MONITORING SETS. THE USER WAS ATTEMPTING TO USE THE SELDINGER TECHNIQUE DURING AN ARTERIAL LINE PLACEMENT PROCEDURE WHEN THE DEVICES FAILED. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED OTHER THAN "REQUIRING MULTIPLE STICKS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420716 SINGLE LUMEN PRESSURE MONITORING SET DQY CATHETER, PERCUTANEOUS DQY COOK INC N/A 9961061 00827002028388

    Patients

    Seq Age Sex Outcome Treatment
    1