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 Leak/Splash (1354)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 07/17/2019

Event Type  malfunction  

Manufacturer Narrative

Occupation: supply department.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.

Event Description

It was reported an ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter was used in an unknown patient for an unknown procedure.As reported, the device was leaking.Additional information regarding the event and patient outcome has been requested but is currently unavailable.

Manufacturer Narrative

D10: product received on: 25jul2019.Investigation/evaluation: a review of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, quality control, and specifications of the device, as well as a visual inspection, functional test, and dimensional verification, were conducted during the investigation.One used device was returned to cook for investigation.It was observed that more than 2 threads were showing between the hub and connector cap.The number of threads showing was determined to be nonconforming.There was no damage on the surface of the hub or catheter tubing.Investigators were able to recreate the failure mode during table-top leak testing.Leakage was observed where the connector cap and hub connect.Additionally, a document based investigation evaluation was performed.The proper procedures are in place to identify and prevent this failure mode prior to device distribution.The risk specifications covering mac-loc drainage catheters include both hub separation and leakage as a potential failure mode.The identified risk controls include manufacturing quality control checks and process validation.The technical files covering mac-loc drainage catheters indicate that the risks associated with these devices are acceptable when weighed against the benefits.A review of the device history record found no related non-conformances with the device lot or sub-assemblies.A database search revealed no other complaints had been reported for the complaint device lot.There is no evidence to suggest there was any nonconforming product in house or out in the field.Based on the information provided, the examination of returned product, and the results of the investigation, a definitive root cause could not be established.Appropriate measures are being conducted to address this failure mode.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.Cook 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 the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

B5 - event description: additional information was received on 29jul2019.The device was placed in the suprapubic area of the patient.The tube was inserted during the first portion of a two part procedure, and the device was found leaking minutes after the first part ended.The patient remained under general anesthesia, was re-prepped, and a new tube was inserted.As reported, there were no adverse effects to the patient to the reporter's knowledge.Concomitant medical product received on: 25jul2019 h6 - patient code: code updated to "no known impact or consequence to patient (2692)." 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.

• 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
• MDR Report Key: 8825665
• MDR Text Key: 152186671
• Report Number: 1820334-2019-01794
• Device Sequence Number: 1
• Product Code: GBO
• UDI-Device Identifier: 00827002110205
• UDI-Public: (01)00827002110205(17)220607(10)9796027
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 08/30/2019

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 Expiration Date: 06/07/2022
• Device Model Number: N/A
• Device Catalogue Number: ULT7.0-35-25-P-5S-CLDM-HC
• Device Lot Number: 9796027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2019
• Initial Date Manufacturer Received: 07/19/2019
• Initial Date FDA Received: 07/25/2019
• Supplement Dates Manufacturer Received: 07/29/2019; 08/28/2019
• Supplement Dates FDA Received: 08/01/2019; 08/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1