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

Catalog Number 081916

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

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

It was reported of a rutner suprapubic balloon catheter set, the device was implanted and then explanted due to a broken connection piece initially.The patient later returned to the facility as the replacement device also broke at the connection piece.The device was removed from the patient and refused to have another device placed.No adverse effects or consequences were reported to the patient due to this occurrence.

Manufacturer Narrative

Investigation ¿ evaluation: the device was not returned for evaluation and no photographs were provided.Without the complaint device, a physical investigation was not able to be completed.A review of quality control data and specifications was conducted.A review of the device history record was not able to be performed as the device lot number was not provided.A review for additional complaints for this device lot could not be completed without the device lot number.There is no indication that a design or process related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.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.Based on the provided information a definitive root cause cannot be established or reported at this time.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: 7147578
• MDR Text Key: 96063639
• Report Number: 1820334-2017-04606
• Device Sequence Number: 1
• Product Code: KOB
• 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: 03/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 081916
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/05/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 87 YR