BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER

    MDR report key: 19645834 · Received July 1, 2024

    Report

    Report Number
    1820334-2024-00888
    Event Type
    Malfunction
    Date Received
    July 1, 2024
    Date of Event
    June 3, 2024
    Report Date
    August 26, 2024
    Manufacturer
    COOK INC
    Product Code
    FGE
    UDI-DI
    00827002137653
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. D2A - COMMON DEVICE NAME: ADDITIONAL NAMES: GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY; LJE CATHETER, NEPHROSTOMY. D2B - PROCODE: ADDITIONAL PRODUCT CODES: GBO, LJE. E1 - CUSTOMER (PERSON): POSTAL CODE: (B)(6). PHONE: (B)(6). 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

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED OR UNAVAILABLE. CORRECTION: D4-MODEL#, H6- ANNEX A INVESTIGATION ¿ EVALUATION ON 05JUN2024, IT WAS REPORTED THAT DURING THE INSERTION OF THE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER NORMAL RESISTANCE WAS ENCOUNTERED PREVENTING SUCCESSFUL INSERTION. THE DEVICE WAS PLACED VIA A ¿ONE STEP¿ TECHNIQUE. THE PROCEDURE WAS COMPLETED USING ANOTHER RPN OF THE SAME DESCRIPTION. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. REVIEWS OF THE DOCUMENTATION, INCLUDING THE COMPLAINT HISTORY, DEVICE HISTORY RECORD AND SPECIFICATIONS AS WELL AS VISUAL INSPECTION OF RETURNED DEVICE, WERE CONDUCTED DURING THE INVESTIGATION. ONE USED ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER WAS RECEIVED IN A USED AND DAMAGED CONDITION. THE INITIAL INVESTIGATION CONFIRMED THE DEVICE EXHIBITED DAMAGE (SPLIT) AT THE DISTAL TIP. THE SPLIT IN THE MATERIAL WAS WITHIN THE ID OF THE CATHETER AND DID NOT EXTEND TO THE OUTSIDE OF THE MATERIAL. DIMENSIONAL ANALYSIS CONFIRMED THAT THE DEVICE AND COMPONENTS WERE MANUFACTURED TO THE CORRECT SPECIFICATIONS AND TOLERANCES. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT INSPECTION ACTIVITIES ARE IN PLACE TO PREVENT THE RELEASE OF NON-CONFORMING PRODUCT RELATED TO THE REPORTED FAILURE MODE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THE DEVICE FOUND NO RELEVANT NONCONFORMANCES THAT COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE MODE. IT SHOULD BE NOTED THAT THERE WERE NO OTHER COMPLAINTS ASSOCIATED WITH THE FINAL PRODUCT LOT NUMBER. COOK ALSO REVIEWED PRODUCT LABELING: THE INSTRUCTIONS FOR USE (IFU) [ T_MULTI2 REV1, MULTIPURPOSE DRAINAGE CATHETER] STATES THE FOLLOWING. HOW SUPPLIED: "UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED." EVIDENCE GATHERED UPON REVIEW OF THE DMR, IFU AND DHR 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, EXAMINATION OF THE RETURNED PRODUCT, AND THE RESULTS OF OUR INVESTIGATION, IT WAS CONCLUDED THAT A COMPONENT FAILURE UNRELATED TO MANUFACTURING OR DESIGN DEFICIENCIES 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 ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER WAS DIFFICULT TO INSERT INTO THE PATIENT. THE DEVICE WAS PLACED VIA A ¿ONE STEP¿ TECHNIQUE. THERE WAS "NORMAL RESISTANCE" WHEN ADVANCING THE DEVICE OVER THE WIRE GUIDE THROUGH THE PATIENT'S SKIN, BUT RESISTANCE ADVANCING THE DEVICE INTO THE PATIENT PREVENT SUCCESSFUL PLACEMENT. THE PROCEDURE WAS COMPLETED WITH AN ADDITIONAL LIKE-DEVICE. THE DEVICE WAS RETURNED TO COOK ON 24JUN2024. PRELIMINARY DEVICE FAILURE ANALYSIS NOTED THE CATHETER¿S TIP WAS SPLIT, THUS PROMPTING THIS REPORT. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1255572 ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK INC G13765 16003022 00827002137653

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown