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

Model Number G14920

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/08/2017

Event Type  malfunction  

Manufacturer Narrative

(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 Description

The user facility reported of a rutner suprapubic balloon catheter set implanted and then explanted due to a broken connection piece.No adverse effects or consequences were reported to the patient due to this occurrence.

Manufacturer Narrative

Investigation ¿ evaluation: the investigation included a review of complaint history, the device history record, drawings, manufacturing instructions, quality control data, and specifications.A visual inspection of the returned device was also conducted.One device was returned for investigation.A visual examination noted the fitting has come off from the tubing.The flare appears to be only on one side of the tubing.The flare did not match the "martini glass" shape.The device history record was reviewed and there were no non-conformances related to the complaint issue.A review of complaint history revealed there have been no other complaints associated with the complaint device lot number 7724789.Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.Current controls for manufacturing are in place to assure functionality; device integrity prior to shipping.Based on the provided information the likely root cause is manufacturing related.Per the quality engineering risk assessment, no further action is required.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.

• Brand Name: RUTNER SUPRAPUBIC BALLOON CATHETER SET
• Type of Device: KOB CATHETER, SUPRAPUBIC (AND ACCESSORIES)
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 7125518
• MDR Text Key: 95849593
• Report Number: 1820334-2017-04605
• Device Sequence Number: 1
• Product Code: KOB
• UDI-Device Identifier: 00827002149205
• UDI-Public: (01)00827002149205(17)180911(10)7724789
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K852287
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G14920
• Device Catalogue Number: 081916
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1