BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER

    MDR report key: 11851988 · Received May 19, 2021

    Report

    Report Number
    1820334-2021-01360
    Event Type
    Malfunction
    Date Received
    May 19, 2021
    Date of Event
    May 3, 2021
    Report Date
    March 18, 2022
    Manufacturer
    COOK INC
    Product Code
    GBO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED OR UNAVAILABLE. INVESTIGATION ¿ EVALUATION. COOK MEDICAL INC. RECEIVED A COMPLAINT FROM PLAZA MEDICAL CENTER IN FORT WORTH, TX REPORTING THE FOLLOWING: WHEN THE SURGICAL TECH FLUSHED THE ULT10.2-38-25-P-6S-CLM-RH, ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER AT THE BEGINNING OF THE PROCEDURE, THE SALINE DID NOT DRIP OUT THE END OF THE DRAIN BUT INSTEAD DRIPPED OUT THE LOCKING MECHANISM. AS A RESULT, ANOTHER DRAIN WAS OPENED. THERE WERE NO ADVERSE EFFECTS EXPERIENCED BY THE PATIENT. REVIEWS OF DOCUMENTATION INCLUDING THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, QUALITY CONTROL PROCEDURES AND SPECIFICATIONS, AS WELL AS A VISUAL INSPECTION AND FUNCTIONAL TEST OF THE RETURNED DEVICE, WERE CONDUCTED DURING THE INVESTIGATION. ONE ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER WAS RETURNED IN A PREPPED CONDITION, WITH TWO PRODUCT LABELS CONTAINING THE LOT NUMBERS 13631101 AND 13580200. A LEAK TEST WAS UNABLE TO CONFIRM LEAKAGE WHEN THE MAC-LOC LEVER WAS PLACED INTO THE LOCKED POSITION. THE DISTANCE BETWEEN THE MAC-LOC ADAPTER AND CONNECTOR CAP WAS WITHIN CURRENT SPECIFICATIONS. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO 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 (DHR) FOR POSSIBLE DEVICE LOTS 13631101 AND 13580200 FOUND NO RELATED NONCONFORMANCES THAT COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE MODE. IT SHOULD BE NOTED THAT THERE WERE NO OTHER COMPLAINTS ASSOCIATED WITH THESE LOT NUMBERS. COOK ALSO REVIEWED PRODUCT LABELING. THE INSTRUCTION FOR USE [T_MULTI_REV5] STATE: "CATHETER PLACEMENT 3. FOR LOCKING LOOP CATHETERS, LOCK THE CATHETER IN PLACE USING APPROPRIATE TECHNIQUE FOR THE LOCKING MECHANISM TYPE, AS DESCRIBED BELOW. FOR MAC-LOC LOCKING LOOP MECHANISM: A. STABILIZE THE MAC-LOC CATHETER HUB ASSEMBLY WITH ONE HAND AND PULL BACK ON THE DRAWSTRING TO FORM THE DISTAL CATHETER LOOP CONFIGURATION. B. WHILE MAINTAINING TRACTION ON THE DRAWSTRING, PUSH THE LOCKING CAM LEVER DOWN UNTIL A DISTINCT "SNAP" IS FELT. THE DISTAL LOOP OF THE CATHETER IS NOW LOCKED INTO POSITION. C. TRIM OFF THE EXCESS DRAWSTRING." EVIDENCE PROVIDED BY THE DEVICE MASTER RECORD REVIEW, DEVICE HISTORY RECORD, DEVICE FAILURE ANALYSIS, AND DESIGN HISTORY FILE SHOW THAT THERE IS NO INDICATION THE DEVICE WAS MANUFACTURED OUT OF SPECIFICATION. THERE IS NO EVIDENCE OF NONCONFORMING MATERIAL IN HOUSE OR 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 WITHOUT ANY DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE EVENT. 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

    D4 - LOT #: EXACT LOT NUMBER IS UNKNOWN, HOWEVER IS POSSIBLY 13580200 OR 13631101. 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

    IN ADDITIONAL INFORMATION RECEIVED ON 24MAY2021, IT WAS REPORTED THAT THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE PATIENT DID NOT RECEIVED A DRAIN, HOWEVER THAT HAD NOTHING TO DO WITH THE PRODUCTS.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER LEAKED FROM THE LOCKING MECHANISM WHILE BEING FLUSHED. AS THE SURGICAL TECH FLUSHED THE CATHETER AT THE BEGINNING TO THE PROCEDURE, THE SALINE DID NOT COME OUT OF THE END OF THE DEVICE AS EXPECTED, BUT RATHER LEAKED FROM THE LOCKING MECHANISM. ANOTHER DRAIN WAS THEN OPENED AND USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. ADDITIONAL INFORMATION REGARDING PATIENT, EVENT AND DEVICE DETAILS HAVE BEEN REQUESTED, BUT ARE CURRENTLY UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745755 ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY GBO COOK INC N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown