MAUDE Adverse Event Report: COOK INC ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER; GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY

Catalog Number	ULT10.2-38-25-P-5S-CLDM-HC
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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 or Problem Description
It was reported a ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter was leaking at the hub connection about ten days after a routine nephrostomy exchange.The patient returned to the facility for an exchange.As reported, the patient did not experience any adverse effects due to this occurrence.
Event or Problem Description
No new event description information to report at this time.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation evaluation.A review of the complaint history, device history record, documentation and visual inspection/dimensional verification/ functional test of the returned device was conducted during the investigation.The used catheter was returned for investigation in an opened condition.The device was returned in two separate pieces and appeared to be cut.No other surface damage was apparent.A leak test was conducted and revealed a leak between the catheter tubing and connector cap.The connector cap was removed revealing that the suture string appeared wound in the threads of the cap and the flare appeared to have been caught in the threads.Device attributes were measured and found to be within manufacturing specification.The device was not out of specification.Additionally, a document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that could contribute to this failure mode.A complaint history search revealed that there were no other reported complaints for this lot number.Based on the information provided and the results of our investigation, a definitive root cause cannot be determined at this time, however appropriate measures have been initiated to address this failure mode.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per quality engineering risk assessment, there is no further actions required at this time.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
• Common Device Name: GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7598267
• Report Number: 1820334-2018-01527
• Device Sequence Number: 178533
• Product Code: GBO
• UDI-Device Identifier: 00827002097063
• UDI-Public: (01)00827002097063(17)201215(10)8450116
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2018

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: ULT10.2-38-25-P-5S-CLDM-HC
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/30/2018
• Supplement Date Received by Manufacturer: 06/20/2018
• Initial Report FDA Received Date: 06/13/2018
• Supplement Report FDA Received Date: 07/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention