BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8503103 · Received April 11, 2019

    Report

    Report Number
    1820334-2019-00831
    Event Type
    Malfunction
    Date Received
    April 11, 2019
    Date of Event
    April 4, 2019
    Report Date
    May 22, 2019
    Manufacturer
    COOK INC
    Product Code
    GBO
    UDI-DI
    00827002137684
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED OR UNAVAILABLE. D10 ¿ PRODUCT RECEIVED ON- 16APR2019. INVESTIGATION ¿ EVALUATION. A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, AND DOCUMENTATION, AS WELL AS A DIMENSIONAL VERIFICATION AND VISUAL INSPECTION, WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS RETURNED IN A USED AND DAMAGED CONDITION. THE VISUAL INSPECTION FOUND THE CATHETER SEPARATED FROM THE HUB. THE FLARE WAS NOTED TO BE DAMAGED SLIGHTLY OUT OF ROUND. THE FLARE CANNOT BE CONFIRMED TO HAVE BEEN MANUFACTURED OUT OF SPECIFICATION BECAUSE THE FLARE IS COMPRESSED WITHIN THE CAP DURING MANUFACTURING PROCESSES. THE ACTION OF THE FLARE BEING PULLED THROUGH THE CAP MAY ALSO HAVE CAUSED THE FLARE TO BECOME OUT OF ROUND.. ALL RELEVANT AND UNDAMAGED DEVICE DIMENSIONS WERE MEASURED TO BE WITHIN SPECIFICATION. ADDITIONALLY, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THE PROPER PROCEDURES ARE IN PLACE TO IDENTIFY AND PREVENT THIS FAILURE MODE PRIOR TO DEVICE DISTRIBUTION. THE RISK SPECIFICATIONS COVERING MAC-LOC DRAINAGE CATHETERS INCLUDE BOTH HUB SEPARATION AND LEAKAGE AS A POTENTIAL FAILURE MODE. THE IDENTIFIED RISK CONTROLS INCLUDE MANUFACTURING QUALITY CONTROL CHECKS AND PROCESS VALIDATION. THE TECHNICAL FILES COVERING MAC-LOC DRAINAGE CATHETERS INDICATE THAT THE RISKS ASSOCIATED WITH THESE DEVICES ARE ACCEPTABLE WHEN WEIGHED AGAINST THE BENEFITS. A REVIEW OF THE DEVICE HISTORY RECORD FOR LOT 9181676 SHOWED NO RELATED NONCONFORMANCES. REVIEW OF RELATED SUBASSEMBLY LOTS SHOWED NO RELATED NONCONFORMANCES. A SOFTWARE SEARCH REVEALED NO OTHER COMPLAINTS FROM LOT 9181676 AT THE TIME OF INVESTIGATION. SINCE THERE ARE NO RELATED NONCONFORMANCES OR OTHER COMPLAINTS FROM THIS LOT, THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN THE FIELD. BASED ON THE INFORMATION PROVIDED, VISUAL INSPECTION OF THE RETURNED DEVICE AND THE RESULTS OF THE INVESTIGATION, A DEFINITIVE CAUSE COULD NOT BE ESTABLISHED APPROPRIATE MEASURES ARE BEING CONDUCTED TO ADDRESS THIS FAILURE MODE. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. 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. 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 THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2019. NO RESISTANCE WAS FELT DURING PLACEMENT OF THE CATHETER. THE CATHETER WAS IN PLACE FOR NINE DAYS BEFORE REMOVAL. DURING REMOVAL, SLIGHT RESISTANCE WAS FELT AND THE HUB SEPARATED FROM THE CATHETER.

    Additional Manufacturer Narrative · 1

    OCCUPATION: UNKNOWN. REPORTED TO A REGULATORY AGENCY: UNKNOWN. PMA/510(K) #: PREAMENDMENT. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER WAS DEPLOYED DURING A PTCD PROCEDURE. AFTER THE TREATMENT OF OBSTRUCTIVE JAUNDICE, THE USER ATTEMPTED TO REMOVE THE COMPLAINT DEVICE, BUT THE HUB BECAME SEPARATED FROM THE CATHETER BODY. THE COMPLAINT DEVICE WAS THEN REMOVED FROM THE PATIENT SUCCESSFULLY. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295563 ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY GBO COOK INC N/A 9181676 00827002137684

    Patients

    Seq Age Sex Outcome Treatment
    1