MAUDE Adverse Event Report: COOK INC; GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY

Model Number	N/A
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter (b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
Customer reported that a patient was undergoing placement of a ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter.Implantation of the device was successful.The customer stated "the drain went in fine, but when they went to inject contrast it was leaking." the customer identified a crack in the device hub.The catheter was exchanged intra-operatively for a new dawson-mueller.There are no reported adverse patient consequences related to this event.The device is reportedly available for evaluation; however it has not been received by the manufacturer as of the date of this report.
Additional Manufacturer Narrative
Investigation - evaluation: a review of functional testing, complaint history, device history record, documentation, drawing, instructions for use, manufacturing instructions, quality control data, and visual inspection of the returned device was conducted during the investigation.Visual inspection and functional testing of the returned device were performed.The catheter was returned separated.The catheter tubing had been cut approximately 7mm from the distal end of the cap.The catheter tubing was able to twist within the proximal assembly.The tubing also moved when tugged upon, but did not come completely out of the joint.Hemostats were used to clamp off the tubing.The proximal assembly was then pressurized with water.By 1 psi (6.9 kpa), water was leaking from the proximal assembly.The cap was unable to be unscrewed from the mac-loc.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.A review of the device history record shows one nonconformance; however the device was scrapped prior to completion of the completed lot.It should be noted there were no other reported complaints for this lot number.Based on the provided information, inspection of returned product, and the investigation results, a definitive root cause cannot be established or reported at this time.Per the quality engineering risk assessment, no further action is required.Appropriate personnel have been notified and monitoring will continue to be performed for similar complaints.

• Common Device Name: GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6777355
• Report Number: 1820334-2017-02243
• Device Sequence Number: 920028
• Product Code: GBO
• UDI-Device Identifier: 00827002104358
• UDI-Public: (01)00827002104358(17)181111(10)6371647
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2017

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 Model Number: N/A
• Device Catalogue Number: ULT12.0-38-25-P-5S-CLDM-HC
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/27/2017
• Supplement Date Received by Manufacturer: 11/20/2017
• Initial Report FDA Received Date: 08/09/2017
• Supplement Report FDA Received Date: 12/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1