MAUDE Adverse Event Report: COVIDIEN DOVER SLVR FOLEYCATH20FR30CC2W; UROLOGY CATHETER

Model Number 630203IC

Device Problems Burst Container or Vessel (1074); Noise, Audible (3273)

Patient Problems Hematoma (1884); Urinary Retention (2119)

Event Date 01/18/2016

Event Type  Injury  

Manufacturer Narrative

Submit date: 2/29/2016.An investigation is currently under way; upon completion the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2016 that a customer had an issue with a urology catheter.The customer reports: patient male, (b)(6), had a radical prostatectomy operation and was placed with a dover silver catheter foley, 20fr 2- way, 30cc.After some days the patient called the doctor to say that he heard a sound like an explosion and when he stood up from the bed the catheter was out with pieces of rubber.The patient presented urine retention.It was not possible to place another catheter due to inflammation.The patient has a separation of the anastomosis uretero vesical with a hematoma in the area.

Manufacturer Narrative

A review of the device history record could not be conducted because a lot number was not provided.Manufacturing records are routinely reviewed prior to the release of product to ensure process and product compliance.A physical sample was not received; however, a picture was received.The reported condition was confirmed.After visual inspection, the balloon catheter burst was confirmed.The root cause identified was related to the molding process of the balloon.Personnel were notified of this issue and the inspection level was changed from normal to tighten on the line.A formal corrective and preventative action (capa) was initiated to address the issue and has been closed with effectiveness.The process is running according to product specifications meeting quality acceptance criteria.If additional information is received warranting further analysis, the investigation will be resumed.This complaint will be used for tracking and trending purposes.

• Brand Name: DOVER SLVR FOLEYCATH20FR30CC2W
• Type of Device: UROLOGY CATHETER
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad; industrial; tijuana ; MX
• Manufacturer (Section G): COVIDIEN; calle 9 sur no. 125 cuidad; industrial; tijuana ; MX
• Manufacturer Contact: thom mcnamara ; 15 hampshire st; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5467895
• MDR Text Key: 39302180
• Report Number: 9612030-2016-00076
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: PM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 630203IC
• Device Catalogue Number: 630203IC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/16/2016
• Initial Date FDA Received: 02/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other