BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DGW .035 FC STR 150CM TEF LLT

    MDR report key: 6286712 · Received January 30, 2017

    Report

    Report Number
    1016427-2017-00165
    Event Type
    Malfunction
    Date Received
    January 30, 2017
    Date of Event
    December 30, 2016
    Report Date
    March 2, 2017
    Manufacturer
    LAKE REGION
    Product Code
    DQX
    PMA / PMN Number
    K864058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF THE ABOVE MENTIONED LOT. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. THE PRODUCT HAS BEEN RETURNED FOR EVALUATION AND TESTING; HOWEVER, THE ENGINEERING EVALUATION HAS NOT BEEN COMPLETED.  ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: A BLACK HAIR WAS FOUND INSIDE THE STERILE CONTENT PACKING OF A GUIDEWIRE. THERE WAS NO REPORT OF PATIENT INJURY AS THE DEVICE WAS NOT CLINICALLY USED. THERE WAS NO DAMAGE TO THE PACKAGING. THE PRODUCT WAS STORED PER THE INSTRUCTION FOR USE (IFU).  NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.  AS RECEIVED, A SPECIMEN CONSISTING OF ONE EACH SFC-B 150-035; RETURNED WITHIN THE SEALED, LABELED SINGLE-PACK MYLAR/TYVEK POUCH. THE SPECIMEN PRESENTED A LOOSE BLACK HAIR WITHIN THE UPPER, RIGHT PORTION OF THE INTERIOR OF THE SEALED POUCH. NO OTHER DAMAGE OR INCONSISTENCIES ARE NOTED TO THE SPECIMEN AT THIS TIME. THE SPECIMEN PRESENTED A LOOSE BLACK HAIR WITHIN THE UPPER, RIGHT PORTION OF THE INTERIOR OF THE SEALED POUCH. A REVIEW OF THE DEVICE HISTORY RECORDS OF THE SPECIMEN DEVICE DOES NOT PRESENT ANY INDICATION OF MANUFACTURING DEFECT OR ANOMALY THAT COULD HAVE IMPACTED ON THE EVENT AS REPORTED. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. FURTHER INVESTIGATIONS REVEALED THAT THE PRODUCT IS 100% INSPECTED FOR VISIBLE DEFECTS, INCLUDING CONTAMINATION AT 18¿ UNAIDED EYE, REVIEWING THE PHOTOGRAPHS PROVIDED BY THE CUSTOMER AND THE RETURNED PRODUCT, THE BLACK HAIR SHOULD HAVE BEEN DETECTED. THE COMPLAINT IS CONFIRMED. AS NOTED ABOVE, THE SPECIMEN PRESENTS A LOOSE BLACK HAIR WITHIN THE UPPER, RIGHT PORTION OF THE INTERIOR OF THE SEALED POUCH. NO OTHER DAMAGE OR INCONSISTENCIES ARE NOTED TO THE SPECIMEN AT THIS TIME. LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF THE ABOVE MENTIONED LOT. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. THE COMPLAINT REPORTED BY THE CUSTOMER AS ¿PACKAGING/ POUCH/BOX-FOREIGN MATERIAL - IN STERILE PACKAGE¿ WAS CONFIRMED AS NOTED IN THE PRODUCT ANALYSIS. LAKE REGION MEDICAL HAS SHIPPED OVER (B)(4) PIECES OF SIMILAR PACKAGED SINGLE PACK PRODUCTS (CORBF-039V) TO CORDIS CORPORATION SINCE JANUARY 2014 AND A REVIEW OF LAKE REGION MEDICAL¿S COMPLAINT DATABASE FOR THE PAST 3 YEARS REVEALED NO ADDITIONAL REPORTED COMPLAINTS FOR CONTAMINATION FROM THIS PACKAGING LOT OR FOR CORBF-039V PRODUCT, TO DATE. AN INVESTIGATION WAS CARRIED OUT COVERING THE POSSIBLE CAUSES, I.E. PEOPLE CAUSE, EQUIPMENT CAUSE, PROCESS CAUSE, MATERIALS CAUSE OR ENVIRONMENT CAUSE. THE ROOT CAUSE FOR THIS INCIDENT WAS DETERMINED TO BE PEOPLE AND EQUIPMENT. A RISK ASSESSMENT HAS BEEN INITIATED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    A BLACK HAIR WAS FOUND INSIDE THE STERILE CONTENT PACKING OF A BENTSON GUIDEWIRE. THERE WAS NO REPORT OF PATIENT INJURY AS THE DEVICE WAS NOT CLINICALLY USED. THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS. THERE WAS NO DAMAGE TO THE PACKAGING.  THE PRODUCT WAS STORED PER IFU.  NO PICTURES ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69603 DGW .035 FC STR 150CM TEF LLT WIRE, GUIDE, CATHETER DQX LAKE REGION 502560 35231194

    Patients

    Seq Age Sex Outcome Treatment
    1