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
Medical Device Problem Codes	Fluid/Blood Leak (1250); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Pma/510(k) #: exempt.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported that a ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter leaked during a gallbladder drainage procedure on an unknown patient.After placement of the catheter via abdominal approach, the user attempted to start drainage but reported that, "he felt strange." contrast media was then used to confirm leakage from damage between the hub and catheter.The leaking device was then removed, and a like device was used to complete the procedure.The patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unchanged, unknown or unavailable.Correction: h6 (annex a).Investigation ¿ evaluation: (b)(6) hospital reported to cook on (b)(6) 2021, that an ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter (ult7.0-35-25-p-5s-cldm-wf-hc) from lot: 14199678 leaked after being placed for biliary drainage.The catheter was removed and replaced successfully.The patient reportedly experienced no adverse effects as a result of this incident.A review of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, quality control, and specifications, as well as a visual inspection, functional test, and dimensional verification of the returned device, were conducted during the investigation.Two catheters were returned in a used condition.Catheter 1, which had intact tubing, failed the gap gauge specification and leaked at the end of the hub when leak tested.Catheter 2, which had a cut tubing, was not initially reported to us.This catheter did not leak and was measured within specification.Additionally, a document-based investigation evaluation was performed.In response to this event, cook completed a review of the product device master record (dmr) and concluded that sufficient controls are in place to detect this failure mode prior to release.The device history record (dhr) for lot: 14199678 showed no related nonconformances.A database search revealed three other complaints under this lot number for this same failure mode at the time of this investigation.Containment was performed on the complaint lot, but field action was not considered based on occurrence.The ifu packaged with the device contains the following in relation to the reported failure mode: inspect the product upon opening to ensure no damage has occurred.The information provided upon review of the dhr and returned device suggests that the device was manufactured out of specification and that there are 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, it was determined the cause of this event is related to manufacturing and quality control deficiency.Catheter 1¿s hub failed the gap gauge specification.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 or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER
• Common Device Name: 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: 12923394
• Report Number: 1820334-2021-02629
• Device Sequence Number: 17340275
• Product Code: GBO
• UDI-Device Identifier: 00827002137684
• UDI-Public: (01)00827002137684(17)240908(10)14199678
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/08/2024
• Device Model Number: N/A
• Device Catalogue Number: ULT7.0-35-25-P-5S-CLDM-WF-HC
• Device Lot Number: 14199678
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/25/2021
• Supplement Date Received by Manufacturer: 07/18/2022
• Initial Report FDA Received Date: 12/03/2021
• Supplement Report FDA Received Date: 08/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown