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 Fluid Discharge (2686)

Event Date 05/31/2023

Event Type  malfunction  

Manufacturer Narrative

Core supervisor.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

A cook ultrathane mac-loc locking loop multipurpose drainage catheter was placed to serve as a nephrostomy tube on (b)(6) 2023.After insertion, while applying the dressing, leaking from the hub was identified.The patient required the ultrathane mac-loc locking loop multipurpose drainage catheter to be removed and replaced.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged or unavailable.Investigation ¿ evaluation.On 07jun2023, cook medical inc.Received a complaint from (b)(6) hospital, located in the city of saskatoon, saskatchewan, ca.Upon the insertion of an ultrathane mac-loc locking loop multipurpose drainage catheter (rpn: ult10.2-38-25-p-6s-clm-rh, lot: 15193225) and applying dressing, it was realized the tube was leaking from the hub.The patient needed to have the tube exchanged again, because the patient could not be sent home with it leaking.The patient did not experience any adverse effects due to this occurrence.Reviews of the documentation, including the complaint history, device history record, instruction for use (ifu), quality control procedures and specifications, as well as a visual inspection and dimensional verification of the returned device, were conducted during the investigation.One device was returned in a used condition.A functional test confirmed leakage from the mac-loc adaptor.Further examination discovered a fold in the flare within the lumen of the mac-loc adaptor.It was later confirmed that the white cap and mac-loc adaptor connection site passed the gap gauge requirement.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are currently in place to prevent the release of nonconforming product related to the reported failure mode.A review of the device history record (dhr) for lot 15193225 and related subassemblies found no relevant nonconformances that could have contributed to the failure of the device.It should be noted that there have been no other leakage complaints associated with the final product lot number.Cook also reviewed product labeling.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: precautions patients with indwelling drainage catheters should be evaluated routinely to ensure continuous function of the catheter.How supplied upon removal from package, inspect the product to ensure no damage has occurred.Evidence gathered upon a review of the dmr, ifu, dhr and returned device suggests that the device was manufactured out of specification.However, there is no evidence that additional product was affected or that non-conforming product from this lot exists 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 manufacturing and quality control deficiency contributed to the event.During the investigation, it was determined the flare was manufactured out of specification.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.

Event Description

No additional information regarding patient and/or event details 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: 17118162
• MDR Text Key: 317320068
• Report Number: 1820334-2023-00729
• Device Sequence Number: 1
• Product Code: GBO
• UDI-Device Identifier: 00827002095021
• UDI-Public: (01)00827002095021(17)260127(10)15193225
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/21/2023

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-6S-CLM-RH
• Device Lot Number: 15193225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/07/2023
• Initial Date FDA Received: 06/13/2023
• Supplement Dates Manufacturer Received: 09/14/2023
• Supplement Dates FDA Received: 09/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2023
• 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