BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FGE CATHETER, BILIARY, DIAGNOSTIC

    MDR report key: 18659699 · Received February 7, 2024

    Report

    Report Number
    1820334-2024-00175
    Event Type
    Injury
    Date Received
    February 7, 2024
    Date of Event
    January 29, 2024
    Report Date
    May 8, 2024
    Manufacturer
    COOK INC
    Product Code
    FGE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D - PRODUCT IDENTIFIER: THE EXACT DEVICE IS CURRENTLY UNKNOWN. THE DEVICE WAS DESCRIBED A 16F COOK DRAIN. PRODUCT CODES AND PMA/510(K) # HAVE BEEN SELECTED BASED ON THE AVAILABLE INFORMATION. D2A - COMMON DEVICE NAME: ADDITIONAL NAMES: GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY; LJE CATHETER, NEPHROSTOMY . D2B - PROCODE: ADDITIONAL PRODUCT CODES: GBO, LJE. G4 ¿ PMA/510(K) #: K173035. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION ¿ EVALUATION: IT WAS REPORTED THAT AN UNKNOWN 16 FRENCH COOK DRAIN LEAKED AT THE HUB. AT AROUND 2-3 PM EST, THE PHYSICIAN NOTICED THE CATHETER WAS LEAKING AT THE HUB. THE CATHETER TUBE WAS CLAMPED, AND AN ADDITIONAL PROCEDURE WAS PERFORMED TO REMOVE AND REPLACE THE DEVICE. UPON REMOVAL OF THE COMPLAINT DEVICE, A HOLE WAS DISCOVERED INSIDE THE CATHETER WHERE THE SHAFT AND THE HUB MEET. IT WAS NOTED THAT THE COMPLAINT DEVICE WAS NOT PLACED BY THE PHYSICIAN WHO DISCOVERED THE LEAKAGE. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT. REVIEWS OF THE DOCUMENTATION, INCLUDING THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE (IFU) AND QUALITY CONTROL PROCEDURES OF THE DEVICE, WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A PHYSICAL EXAMINATION COULD NOT BE CONDUCTED. HOWEVER, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THE EXACT DEVICE COULD NOT BE CONDUCTED DUE TO THE LACK OF LOT INFORMATION PROVIDED BY THE FACILITY. AN EXPANDED SALES SEARCH FROM 01JAN2021 TO 30JAN2024 IDENTIFIED A POSSIBLE RPN FOR A MULTIPURPOSE DRAINAGE CATHETER; HOWEVER, THE REVIEW OF SALES RECORDS FOR THAT DEVICE WAS UNABLE TO SUFFICIENTLY NARROW DOWN A LOT NUMBER. COOK ALSO REVIEWED PRODUCT LABELING. THE PRODUCT IFU, [T_MULTI2_REV1] ¿MULTIPURPOSE DRAINAGE CATHETER,¿ STATES: "PRECAUTIONS: WHEN INSERTING A STIFFENING CANNULA INTO A CATHETER WITH RETENTION SUTURE, HOLD SUTURE DURING CANNULA INSERTION TO AVOID BUNCHING OR TANGLING OF SUTURE. HOW SUPPLIED: SUPPLIED STERILIZED BY ETHYLENE OXIDE GAS IN PEEL-OPEN PACKAGES. INTENDED FOR ONE-TIME USE. STERILE IF PACKAGE IS UNOPENED OR UNDAMAGED. DO NOT USE THE PRODUCT IF THERE IS DOUBT AS TO WHETHER THE PRODUCT IS STERILE. STORE IN A DARK, DRY, COOL PLACE. AVOID EXTENDED EXPOSURE TO LIGHT. UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED.¿ EVIDENCE PROVIDED UPON REVIEW OF THE DMR, DHR, AND IFU SUGGESTS THAT THE DEVICE WAS NOT MANUFACTURED OUT OF SPECIFICATION, AND THAT THERE ARE NO NONCONFORMING DEVICES IN HOUSE OR OUT IN THE FIELD. BASED ON THE INFORMATION PROVIDED, NO RETURNED PRODUCT, AND THE RESULTS OF OUR INVESTIGATION, IT WAS CONCLUDED THAT A COMPONENT FAILURE WITHOUT ANY DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE REPORTED EVENT. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNKNOWN 16 FRENCH COOK DRAIN LEAKED AT THE HUB. AT AROUND 2-3 PM EST, THE PHYSICIAN NOTICED THE CATHETER WAS LEAKING AT THE HUB. THE CATHETER TUBE WAS CLAMPED, AND AN ADDITIONAL PROCEDURE WAS PERFORMED TO REMOVE AND REPLACE THE DEVICE. UPON REMOVAL OF THE COMPLAINT DEVICE, A HOLE WAS DISCOVERED INSIDE THE CATHETER WHERE THE SHAFT AND THE HUB MEET. IT WAS NOTED THAT THE COMPLAINT DEVICE WAS NOT PLACED BY PHYSICIAN WHO DISCOVERED THE LEAKAGE. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1228263 FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK INC N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention