MAUDE Adverse Event Report: COOK INC ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER; GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2023

Event Type  malfunction  

Event Description

An ultrathane mac-loc locking loop multipurpose drainage catheter was placed in the chest.Leaking was reported from the hub of the catheter.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.Additional information regarding the event and patient outcome has been requested but is currently unavailable.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.E1: postal code: (b)(6).G4: 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 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 or that a death or serious injury occurred; nor is it admission that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: b5 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 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 or that a death or serious injury occurred; nor is it admission that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

Additional information was received indicating that device leakage was noted on immediate insertion.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown, or unavailable.Investigation ¿ evaluation.On 26apr2023, cook australia received a complaint from (b)(6) (australia).They report that during a procedure, using an ultrathane mac-loc locking loop multipurpose drainage catheter (rpn: ult8.5-38-25-p-6s-clm-rh; lot: 14818876) for chest drain, leakage from the mac-loc hub was observed.No adverse effects for the patient were reported.Reviews of the complaint history, device history record (dhr), instructions for use (ifu), manufacturing instructions, and quality control procedures, as well as a visual inspection, functional test, and dimensional verification of one unused device, were conducted during the investigation.The customer did not return the used device.However, one unused device, having the same rpn and lot number was returned in an unopened condition.The investigation confirmed there was one thread showing between the cap / mac-loc adapter connection site, passing the required gap gauge requirement.A leak test of the device was unable to replicate the customers difficulty.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 has concluded that sufficient inspection activities are currently in place to prevent the release of non-conforming product related to the reported failure mode.Cook also reviewed the device history record (dhr).The dhr for lot 14818876 and all related subassembly and raw material lots recorded no relevant non-conformances.To date, a further search of our database records revealed one additional complaint (mfr.Reference # 1820334-2023-00553) being received.This also involved leakage at the connection site of the mac-loc and catheter.Both devices were reported from the same facility.Since there is objective evidence the dhr was fully executed, and there are no other lot-related complaints from other facilities, in addition to the unopened / unused device showing no leakage during leak testing, cook medical inc.Has concluded that there is no evidence that non-conforming product exists in house, in the field and that the device was manufactured to current specification.Cook also reviewed product labeling.The ifu packaged with the device contains the following in relation to the reported failure mode: precautions: ¿for best results, keep catheter surface wet during placement." how supplied: "upon removal from package, inspect the product to ensure no damage has occurred." based on the information provided, inspection of the returned unused device, and the results of the investigation, it was determined the cause of this event is related to a component failure, without any design or manufacturing issue.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.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER
• Type of Device: GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 16896962
• MDR Text Key: 314850047
• Report Number: 1820334-2023-00576
• Device Sequence Number: 1
• Product Code: GBO
• UDI-Device Identifier: 00827002095014
• UDI-Public: (01)00827002095014(17)250629(10)14818876
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-38-25-P-6S-CLM-RH
• Device Lot Number: 14818876
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/26/2023
• Initial Date FDA Received: 05/09/2023
• Supplement Dates Manufacturer Received: 05/14/2023; 07/17/2023
• Supplement Dates FDA Received: 05/18/2023; 08/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1