MAUDE Adverse Event Report: COVIDIEN P400 PREM U/M 16FR CATH SECURE; URINARY CATHETER

Model Number	P4P16SD
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/09/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Submit date: 10/03/2016.An investigation is currently underway; upon completion the results will be forwarded.
Event or Problem Description
It was reported to covidien on (b)(6) 2016 that a customer had an issue with a urinary catheter.The customer reports that the foley catheter snapped (broke) after they placed it and tugged to ensure placement.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.A sample was received for evaluation.A visual inspection was performed and the catheter was broken.The contact of the catheter in the wall oven section could have weakened the middle section of the catheter.A corrective action is not required at this time.This complaint will be used for tracking and trending purposes.

• Brand Name: P400 PREM U/M 16FR CATH SECURE
• Common Device Name: URINARY CATHETER
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad; industrial; tijuana ; MX
• MDR Report Key: 5994926
• Report Number: 9612030-2016-00484
• Device Sequence Number: 93254
• Product Code: EZL
• UDI-Device Identifier: 10884521029613
• UDI-Public: 0110884521029613
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2016

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: Other
• Device Model Number: P4P16SD
• Device Catalogue Number: P4P16SD
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/12/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/03/2016
• Supplement Report FDA Received Date: 12/05/2016
• Patient Sequence Number: 1