BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLON DECOMPRESSION SET

    MDR report key: 13534106 · Received February 15, 2022

    Report

    Report Number
    3001845648-2022-00083
    Event Type
    Malfunction
    Date Received
    February 15, 2022
    Date of Event
    January 17, 2022
    Report Date
    October 10, 2022
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FEG
    UDI-DI
    00827002221819
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K171619. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K171619. DEVICE EVALUATION: 1 X CDSG-14-175 OF LOT NUMBER C1863002 INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. DOCUMENT REVIEW INCLUDING IFU REVIEW: PRIOR TO DISTRIBUTION CDSG-14-175 DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. A REVIEW OF THE MANUFACTURING RECORDS FOR CDSG-14-175 OF LOT NUMBER C1863002 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. THE REVIEW OF RELEVANT MANUFACTURING RECORDS CONFIRMS THE FAILURE MODE HAS NOT PREVIOUSLY OCCURRED WITH THE CURRENT LOT NUMBER. BASED ON THE INFORMATION AVAILABLE TO DATE, THERE IS NO EVIDENCE TO SUGGEST THAT THERE ARE ANY MANUFACTURING ISSUES ASSOCIATED WITH LOT NUMBER C1863002. THE INSTRUCTIONS FOR USE (IFU0102-4) STATES THE FOLLOWING: ¿IF PACKAGE IS OPENED OR DAMAGED WHEN RECEIVED, DO NOT USE. VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BREAKS. IF AN ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE.¿ ROOT CAUSE REVIEW: A DEFINITE ROOT CAUSE CANNOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION AND DUE TO LIMITED INFORMATION. ENGINEERING INPUT COULD NOT DETERMINE COULD NOT DETERMINE WHAT MAY HAVE CAUSED THE CATHETER TO GET STUCK AND SUBSEQUENTLY SNAP BASED ON THE INFORMATION AVAILABLE. SEVERAL ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER, BUT THIS INFORMATION HAS NOT BEEN FORTHCOMING, IF IT IS RECEIVED AT A LATER DATE THE INVESTIGATION WILL BE UPDATED ACCORDINGLY. SUMMARY: COMPLAINT IS BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INFORMATION REPORTED, THERE WAS NO ADVERSE EFFECTS TO THE PATIENT OR ADDITIONAL PROCEDURES REQUIRED. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    THE INNER CATHETER GOT STUCK AND SNAPPED WHEN TAKEN OUT. THE BROKEN PART WAS THEN FINALLY PULLED OUT. NO PATIENT INJURY. PRODUCT AND PACKAGE DISPOSED OF. "AS PER CC FORM": THE INNER CATHETER GOT STUCK AND SNAPPED WHEN TAKEN OUT. THE BROKEN PART WAS THEN FINALLY PULLED OUT. NO PATIENT INJURY. PRODUCT AND PACKAGE DISPOSED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669719 COLON DECOMPRESSION SET FEG TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION FEG COOK IRELAND LTD G22181 C1863002 00827002221819

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown