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 Fluid/Blood Leak (1250)

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

Event Date 06/16/2023

Event Type  malfunction  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.E1 - customer (person) - line 2: (b)(6).Phone: (b)(6).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.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

It was reported that the hub of an ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter leaked during placement in an unknown patient.When the physician went to aspirate fluid from the catheter following insertion, leakage was noted on the patient side of the hub.The user found that only air could be aspirated, while the fluid poured out the side of the tube.The physician then put in a new catheter; however, the suture string broke during an attempt to lock the device.The procedure was completed successfully with a new-like device in a third attempt.The patient did not require any additional procedures or experience any adverse effects due to this occurrence.This report captures the instance of fluid leakage from the hub of the catheter.

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.Investigation evaluation: an issue was reported with a ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter (ult8.5-38-25-p-5s-cldm-hc) from lot 15129359.After insertion into the patient, when the physician attempted to aspirate fluid, fluid was noted to be leaking from the hub.Cook became aware of this event on (b)(6) 2023 upon being notified by queensland x-ray ¿ greenslopes, queensland, australia.The patient did not require any further procedures.However, the procedure took longer as three attempts were required to complete the procedure.The patient reportedly experienced no adverse effects as a result of this incident.Reviews of documentation including the complaint history, device history record (dhr), quality control, specifications, and instructions for use (ifu), as well as a visual inspection and functional test of the returned device, were conducted during the investigation.The complainant returned one used catheter to cook for investigation.A leak was confirmed during the leak test.Visual inspection found the flare folded inward inside the hub.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 (15129359) and subassembly lots revealed one related nonconformance, in which seven devices were scrapped.It should be noted that there were three other complaints for leakage associated with the final product lot number at the time of the investigation.The information provided upon review of the dhr and returned device suggests that the device was manufactured out of specification and that there are possible nonconforming devices in the field.Containment was performed on related lots, but field action was determined not to be necessary.Cook also reviewed product labeling.The ifu packaged with the device contains the following in relation to the reported failure mode: instructions for use (ifu) document t_multi2_rev1 is packaged with this device.The product ifu states the following in consideration of the reported failure mode: ¿how supplied: upon removal from package, inspect the product to ensure no damage has occurred.¿ based on the information provided, inspection of the returned device, and the results of our investigation, cook has concluded a manufacturing deficiency at the supplier contributed to this incident.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 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: 17172927
• MDR Text Key: 317625885
• Report Number: 1820334-2023-00788
• Device Sequence Number: 1
• Product Code: GBO
• UDI-Device Identifier: 00827002097056
• UDI-Public: (01)00827002097056(17)251219(10)15129359
• 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: 11/02/2023

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-5S-CLDM-HC
• Device Lot Number: 15129359
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/19/2023
• Initial Date FDA Received: 06/21/2023
• Supplement Dates Manufacturer Received: 10/09/2023
• Supplement Dates FDA Received: 11/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2022
• 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