BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 13286041 · Received January 18, 2022

    Report

    Report Number
    1820334-2022-00083
    Event Type
    Malfunction
    Date Received
    January 18, 2022
    Date of Event
    January 11, 2022
    Report Date
    October 21, 2022
    Manufacturer
    COOK INC
    Product Code
    GBO
    UDI-DI
    00827002104365
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6). PMA/510(K) #: EXEMPT. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNCHANGED, UNKNOWN, OR UNAVAILABLE. INVESTIGATION ¿ EVALUATION. ON 11JAN2022 COOK INDIA RECEIVED A COMPLAINT FROM DR. (B)(6) , A REPRESENTATIVE AT THE (B)(6), LOCATED IN THE CITY OF (B)(6). IT WAS REPORTED THAT DURING THE PREPPING PROCESS OF THE ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER (ULT14.0-38-25-P-5S-CLDM-HC; LOT: #13997224), THE CATHETER SEPARATED FROM THE HUB. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT MADE, AND NO ADVERSE EFFECTS WERE REPORTED. REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), INSTRUCTIONS FOR USE (IFU) AND QUALITY CONTROL PROCEDURES, AS WELL AS A VISUAL INSPECTION OF THE RETURNED DEVICE, WERE CONDUCTED DURING THE INVESTIGATION. THE DEVICE WAS RETURNED IN AN OPENED, PREPPED BUT DAMAGED CONDITION. THE CATHETER WAS RECEIVED WITH THE METAL STIFFENER INSERTED INTO THE MAC-LOC AND CATHETER, WITH THE PROXIMAL END OF THE CATHETER SEPARATED FROM THE MAC-LOC ADAPTOR. THE CAP AND MAC-LOC ADAPTOR WERE DISSEMBLED, CONFIRMING THERE WAS NO CATHETER MATERIAL CAUGHT BETWEEN THE CAP AND ADAPTOR. A VISUAL EXAMINATION DISCOVERED THE FLARE NOT TO BE OF SIZE AND EXHIBITING A SLANT WITH UNEVENNESS. THERE WAS EVIDENCE OF MATERIAL ELONGATION IN THE FLARE. BASED ON THE EVIDENCE DISPLAYED, COOK MEDICAL CONCLUDED THE FLARE WAS MANUFACTURED OUT OF SPECIFICATION. AS A RESULT OF THIS DISCOVERY, A DEFECT AWARENESS RETRAINING FORM WAS ISSUED TO THE APPROPRIATE INDIVIDUAL RESPONSIBLE FOR THE FLARING OF THE CATHETER. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. IN RESPONSE TO THIS INCIDENT, COOK COMPLETED A REVIEW OF THE PRODUCT DEVICE MASTER RECORD (DMR) AND CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO PREVENT THE RELEASE OF NONCONFORMING PRODUCT RELATED TO THE REPORTED FAILURE MODE. THE RISK SPECIFICATIONS COVERING MAC-LOC DRAINAGE CATHETERS INCLUDES HUB SEPARATION AS A POTENTIAL FAILURE MODE. THE IDENTIFIED RISK CONTROLS INCLUDE THE 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. COOK REVIEWED THE DEVICE HISTORY RECORD (DHR). THE DHR FOR LOT 13997224, SUBASSEMBLY LOTS SA13822623 AND SA13851771, AND RAW MATERIAL LOT 2127673.1 ALL RECORD NO RELEVANT NONCONFORMANCES OR ADDITIONAL COMPLAINTS. BASED ON THIS INFORMATION, COOK DID NOT CONCLUDE THAT ADDITIONAL NONCONFORMING MATERIAL WAS IN HOUSE OR IN THE FIELD. COOK ALSO REVIEWED PRODUCT LABELING. THE IFU SUPPLIED WITH THE MAC-LOC DRAINAGE CATHETERS INSTRUCT THAT THE PRODUCT SHOULD BE INSPECTED PRIOR TO USE TO ENSURE NO DAMAGE HAS OCCURRED. BASED ON THE INFORMATION PROVIDED, INSPECTION OF THE RETURNED DEVICE, AND THE RESULTS OF THE INVESTIGATION, IT WAS DETERMINED THE CAUSE OF THIS EVENT IS RELATED TO A MANUFACTURING DEFICIENCY. IT WAS DETERMINED THE FLARE WAS MANUFACTURED OUT OF SPECIFICATION. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. 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 THE HUB OF A ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER BROKE PRIOR TO USE. A PHOTO PROVIDED BY THE CUSTOMER SHOWS THE HUB OF THE CATHETER SEPARATED FROM THE CATHETER SHAFT. ANOTHER PRODUCT WAS OPENED TO COMPLETE THE BILIARY DRAINAGE PROCEDURE SUCCESSFULLY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS 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
    1052380 ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY GBO COOK INC N/A 13997224 00827002104365

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Male