MAUDE Adverse Event Report: COOK INC RUTNER SUPRAPUBIC BALLOON CATHETER SET; KOB CATHETER, SUPRAPUBIC (AND ACCESSORIES)

Model Number	G15261
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).(b)(4).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 the rutner suprapubic balloon catheter was placed for percutaneous cystostomy, but the urine drainage was not confirmed next day.The customer found the catheter easily came off and the balloon was deflated.To find out what was the cause, he put the balloon into the water and attempted to inflate and confirmed the balloon would not inflate.He replaced it with another balloon.The patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Additional information: investigation ¿ evaluation.A visual inspection and functional testing of the returned device was conducted.A document based investigation was also performed including a review of complaint history, the device history record, drawings, instructions for use, manufacturing instructions, quality control data, and specifications.One rutner suprapubic balloon catheter set was returned for investigation.A leak test determined that the balloon leaks at the distal thread.A review of the device history record found there were no non-conformances associated with lot number ns8513221.A search of complaint records revealed this is the only complaint for complaint device lot number ns8513221.There is no indication that a design process or related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.The returned rutner suprapubic balloon catheter was found to have a leak at the distal end of the balloon.The cause of the leak could not be established.Measures have been initiated to address this failure mode.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.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.
Event or Problem Description
There has been no new information received since the last report was submitted.

• Brand Name: RUTNER SUPRAPUBIC BALLOON CATHETER SET
• Common Device Name: KOB CATHETER, SUPRAPUBIC (AND ACCESSORIES)
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7942447
• Report Number: 1820334-2018-03026
• Device Sequence Number: 16336277
• Product Code: KOB
• UDI-Device Identifier: 00827002152618
• UDI-Public: (01)00827002152618(17)190716(10)NS8513221
• Combination Product (Y/N): N
• PMA/510(K) Number: K852287
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/16/2019
• Device Model Number: G15261
• Device Catalogue Number: 081912
• Device Lot Number: NS8513221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2018
• Initial Date Received by Manufacturer: 09/25/2018
• Supplement Date Received by Manufacturer: 10/31/2018
• Initial Report FDA Received Date: 10/08/2018
• Supplement Report FDA Received Date: 11/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1