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 Insufficient Information (4580)

Event Date 08/08/2023

Event Type  malfunction  

Event Description

It was reported that an ultrathane mac-loc locking loop multipurpose drainage catheter leaked between the cap and the mac-loc.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 the patient and/or event 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.Correction: h3 d2a - additional common name: gbo catheter, nephrostomy, general & plastic surgery; lje catheter, nephrostomy d2b - additional product code: gbo; lje.G4 - pma/510(k) #: k173035 investigation ¿ evaluation it was reported that an ultrathane mac-loc locking loop multipurpose drainage catheter leaked between the cap and the mac-loc.Additional information regarding the event and patient outcome is currently unavailable.Reviews of documentation including the complaint history, device history record (dhr), quality control procedures, manufacturing instructions (mi), and instructions for use (ifu) of the complaint device were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, 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 and the related subassembly lots revealed no relevant non-conformances.To date, there has been no additional complaints received from this lot.Cook reviewed the product labeling for the complaint device.The instructions for use (ifu) [ t_multi2_rev1, multipurpose drainage catheter] states 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." the information provided upon review of the dmr, ifu, and dhr, suggests that the device was not manufactured out of specification, and that there are no nonconforming devices in house or out in the field.Based on the information provided, no product returned, and the results of the investigation, the cause of this event is component failure unrelated to manufacturing or design deficiencies.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.

• 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: 17573103
• MDR Text Key: 321468207
• Report Number: 1820334-2023-01106
• Device Sequence Number: 1
• Product Code: GBO
• UDI-Device Identifier: 00827002095014
• UDI-Public: (01)00827002095014(17)260410(10)15378479
• 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
• Report Date: 12/28/2023
• 2 Devices were Involved in the Event: 1 2

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: 15378479
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/09/2023
• Initial Date FDA Received: 08/18/2023
• Supplement Dates Manufacturer Received: 12/04/2023
• Supplement Dates FDA Received: 12/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1