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 Problems Discomfort (2330); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

T was reported that leakage was observed between the cap and hub of an ultrathane mac-loc locking loop multipurpose drainage catheter.The user noted that the suture thread was observed to be sticking out of the locking hub and tube junction.As a result, urine began to "wick" up the thread, leading to leakage.This was unpleasant to the patient and caused further discomfort.This occurred with 8.5fr and 10.2fr drains.This report captures an 8.5fr drain where leakage occurred due to the suture thread sticking out of the hub and tube junction.Other instances of this malfunction in devices that did not make patient contact are captured in reports with patient identifier: (b)(6) and (b)(6).Additional information regarding event details has been requested but is currently unavailable.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.E3 - occupation: acting charge nurse manager.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

Investigation ¿ evaluation: on 01may2023, cook australia received a complaint from the (b)(6) hospital, located in (b)(6).It was reported that leakage was observed between between the cap and mac-loc adaptor of an ultrathane mac-loc locking loop multipurpose drainage catheter (rpn: ult8.5-38-25-p-6s-clm-rh; lot# 15114369).The user noted that the suture thread was observed to be sticking out of the locking hub and tube junction.As a result, urine began to "wick" up the thread, leading to leakage.This investigation captures an 8.5fr drain where leakage occurred.An additional instance of suspected leakage in a device that did not make patient contact is captured in report with mdr #: 1820334-2023-00548.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, functional test, and dimensional verification of a returned, unused product, were conducted during the investigation.The ult8.5-38-25-p-6s-clm-rh, ultrathane mac-loc locking loop multipurpose drainage catheter, lot number 15114369 was not returned.However, one ult10.2-38-25-p-6s-clm-rh, ultrathane mac-loc locking loop multipurpose drainage catheter, lot 14974153 was returned, sealed within an inner pouch.During tabletop testing using a syringe and water, the catheter showed no evidence of leakage.The investigation confirmed there was one thread showing between the cap / mac-loc adapter connection site; however, the distance between the cap and the hub was measured and determined to be within of specification.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 and the related subassembly lots revealed no recorded non-conformances relevant to the failure mode.A database search did not identify any other events associated with the reported device lot.Based on the available information, cook has concluded that the device was manufactured to specification and that there is no evidence suggesting nonconforming product exists either in house or in field.Cook also reviewed product labeling.The ifu [t_multi2_rev1] supplied with the device states in relation to the reported failure mode that the product should be inspected prior to use to ensure no damage has occurred.Based on the available information, inspection of the returned, unopened device, and the results of the investigation, cook medical has concluded that component failure unrelated to manufacturing or design deficiencies contributed to the failure mode.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 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.

• 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: 16872856
• MDR Text Key: 314976137
• Report Number: 1820334-2023-00549
• Device Sequence Number: 1
• Product Code: GBO
• UDI-Device Identifier: 00827002095014
• UDI-Public: (01)00827002095014(17)251208(10)15114369
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/14/2023

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: 15114369
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/01/2023
• Initial Date FDA Received: 05/04/2023
• Supplement Dates Manufacturer Received: 08/21/2023
• Supplement Dates FDA Received: 09/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2022
• 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