BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 15668922 · Received October 25, 2022

    Report

    Report Number
    1820334-2022-01656
    Event Type
    Malfunction
    Date Received
    October 25, 2022
    Date of Event
    October 24, 2022
    Report Date
    March 3, 2023
    Manufacturer
    COOK INC
    Product Code
    GBO
    UDI-DI
    00827002097056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION ¿ EVALUATION: ON 25OCT2022, COOK CHINA RECEIVED A COMPLAINT FROM A REPRESENTATIVE AT THE SHANGHAI RUIJIE MEDICAL EQUIPMENT CO, LTD FACILITY, LOCATED IN THE CITY OF SHANGHAI, CN. UPON THE PLACEMENT OF THE ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER (RPN: ULT8.5-38-25-P-5S-CLDM-HC, LOT: 14581831) LEAKAGE WAS FOUND AT THE JUNCTION OF CATHETER. THE DEVICE WAS THEN REPLACED WITH A NEW CATHETER. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. REVIEWS OF THE DOCUMENTATION, INCLUDING THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE (IFU), QUALITY CONTROL PROCEDURES AND SPECIFICATIONS, AS WELL AS A VISUAL INSPECTION, FUNCTIONAL TEST AND DIMENSIONAL VERIFICATION OF THE RETURNED DEVICE, WERE CONDUCTED DURING THE INVESTIGATION. ONE USED DEVICE WAS RETURNED FOR EVALUATION. AN EXAMINATION OF THE THREADS BETWEEN THE CAP AND MAC-LOC ADAPTER CONNECTION SITE CONFIRMED THAT IT WAS WITHIN SPECIFICATION. A FUNCTIONAL TEST WAS UNABLE TO CONFIRM LEAKAGE FROM THE DEVICE. THE LUMEN OF THE MAC-LOC ADAPTER WAS CONFIRMED TO BE UNOBSTRUCTED, THUS ELIMINATING THE CONCERN THAT THE FLARE MAY HAVE BEEN FOLDED. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE CURRENTLY IN PLACE TO PREVENT THE RELEASE OF NONCONFORMING PRODUCT RELATED TO THE REPORTED FAILURE MODE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR LOT 14581831 FOUND ONE NONCONFORMANCE FOR ¿FAILED GAP GAUGE,¿ IN WHICH ONE DEVICE WAS SCRAPPED PRIOR TO FURTHER PROCESSING. 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, ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER] STATES THE FOLLOWING. REVIEW OF PRODUCT LABELING: A TFE COATED WIRE GUIDE MUST BE USED WITH ULTRATHANE CATHETERS. ACTIVATE THE HYDROPHILIC COATING, IF PRESENT, BY WETTING THE CATHETER WITH STERILE WATER OR SALINE. FOR BEST RESULTS, KEEP CATHETER SURFACE WET DURING PLACEMENT. CATHETERS SHOULD BE IRRIGATED ON A ROUTINE BASIS TO ENSURE FUNCTION. 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 INCIDENT. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. WE 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.

    Additional Manufacturer Narrative · 0

    (B)(6). OCCUPATION: UNKNOWN. PMA/510(K) #: EXEMPT. 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.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING THE PROCEDURE THE ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER HAD A LEAKAGE AT THE HUB OF THE CATHETER. THE PHYSICIAN THEN REPLACED IT WITH ANOTHER NEW CATHETER SUCCESSFULLY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2573700 ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY GBO COOK INC N/A 14581831 00827002097056

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown