MAUDE Adverse Event Report: COVIDIEN 3.5/5.0FR PU UVC TRAY; CATHETER, UMBILICAL ARTERY

Model Number	8888160119
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Event or Problem Description
As per the customer, the nurse noticed bubbling below the ports of the umbilical venous catheter (uvc).The catheter had a hole in it and being used on a patient.There was no patient harm reported.

• Brand Name: 3.5/5.0FR PU UVC TRAY
• Common Device Name: CATHETER, UMBILICAL ARTERY
• Manufacturer (Section D): COVIDIEN; edificio b20 calle #2 zona fra; alajuela ; CS
• MDR Report Key: 9244950
• Report Number: 3009211636-2019-00675
• Device Sequence Number: 19454555
• Product Code: FOS
• UDI-Device Identifier: 10884527005093
• UDI-Public: 10884527005093
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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
• Report Date (Section B): 10/28/2019

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: No Information
• Device Model Number: 8888160119
• Device Catalogue Number: 8888160119
• Device Lot Number: 1182698
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2019
• Initial Report FDA Received Date: 10/28/2019
• Patient Sequence Number: 1