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

Model Number N/A

Device Problem Leak/Splash (1354)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/28/2023

Event Type  malfunction  

Event Description

It was reported that an ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter leaked.After the device was placed in the patient, it was noted that the collection bulb attached to the drain was slowly losing suction.The bulb was replaced.Later, it was reported that the bulb was still losing suction over the period of an hour.As a result, the drain was removed on (b)(6) 2023.The customer placed the catheter in a container of water to test for a leak.A photo was provided showing a leak between the catheter cap and mac-loc hub.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 or unavailable.G4- 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 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

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

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.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 correction: h6 - annex e, annex f investigation ¿ evaluation on 31jul2023, cook medical inc.Received a complaint from the kaiser oakland mc home health, located in the city of oakland ca.It was reported that a ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter (rpn: ult10.2-38-25-p-5s-cldm-hc; lot: 15483788) leaked.After the device was placed in the patient, it was noted that the collection bulb attached to the catheter was slowly losing suction.The bulb was replaced.Later, it was reported that the bulb was still losing suction, so the bulb was reset every 30 minutes.The catheter was only required for a day and half; therefore, it was not replaced.Upon removal, the catheter was tested and leakage was discovered.The patient did not experience any adverse or effects or require any additional procedures.Reviews of documentation including the complaint history, device history record (dhr), quality control procedures, and instructions for use (ifu), as well as a visual inspection and functional test of the returned device, were conducted during the investigation.One used drainage catheter was returned to cook for evaluation.The distance between the cap and the hub was measured and determined to be within specification.During table top testing, a leak test confirmed fluid escaping from the cap / mac-loc adaptor connection site.Upon disassembling of the cap and mac-loc adaptor, the flare was discovered to be partially torn near the top.Thread marks in the flare were present.Based on the evidence displaced, the flare appeared to be too large which prevented an inadequate seal that resulted in device leakage.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.A review of the dhrs for the reported complaint device lot 15483788 and the related subassembly lots revealed one relevant non-conformance for "flare inadequate"; two devices were scrapped prior to further processing of the order.A database search identified one other event associated with the complaint lot for an unrelated failure mode.Cook reviewed the product labeling for the complaint device.The instructions for use (ifu) [ t_multi2 rev1, multipurpose drainage catheter] packaged with the device contains the following in relation to the reported failure mode: how supplied: "upon removal from package, inspect the product to ensure no damage has occurred." the information provided upon review of the returned device suggests that the device was manufactured out of specification.However, review of the dmr and dhr suggests that there are no additional nonconforming devices in house or out in the field.Based on the information provided, inspection of the returned device, and the results of the investigation, cook concluded the main cause of failure is manufacturing-related, due to an inadequate flare.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

Per additional information provided on 17oct2023, the leakage of the device was present from the beginning of placement.However, it was noticed a few hours after the patient went to the floor due to the leakage being just slow enough that it was not recognized immediately upon insertion.The collection bulb would slowly loose suction over time; therefore, the patient had to reset the collection bulb every 30 minutes for the duration while the device was in place.The drainage catheter was only needed for a day and a half.Therefore, an additional drain did not need to be inserted.The patient did not experience any adverse effects, but the drainage process was slower due to the patient not resetting the collection bulb when asleep.

• Brand Name: ULTRATHANE DAWSON-MUELLER 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: 17443949
• MDR Text Key: 320242769
• Report Number: 1820334-2023-01009
• Device Sequence Number: 1
• Product Code: GBO
• UDI-Device Identifier: 00827002097063
• UDI-Public: (01)00827002097063(17)260612(10)15483788
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/31/2023

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: ULT10.2-38-25-P-5S-CLDM-HC
• Device Lot Number: 15483788
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/31/2023
• Initial Date FDA Received: 08/02/2023
• Supplement Dates Manufacturer Received: 08/30/2023; 10/16/2023
• Supplement Dates FDA Received: 08/31/2023; 10/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2023
• 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