MAUDE Adverse Event Report: COVIDIEN 5.0FR URETHANE UMB CATH; CATHETER, UMBILICAL ARTERY

Model Number	8888160341
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/13/2020
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.
Event or Problem Description
The customer reported that the catheter started leaking near the hub two days after insertion.Additional information received from the customer stated the catheter was removed and a new catheter was inserted by the provider.
Additional Manufacturer Narrative
Evaluation summary: because no lot number was identified, a manufacturing device history record (dhr) review or product/process changes review for the involved lot number could not be performed.However, all dhrs are reviewed for accuracy prior to product release.One used catheter was received at the manufacturing site for analysis and investigation.Visual inspection of the sample showed signs of use.During the evaluation, the catheter showed a leak below the strain relief.The reported event was confirmed.The manufacturing site performs 100% leak testing per procedure, which would identify leaking in the catheter assembly.The instructions for use warn to not use sharp clamps or instruments to handle the catheter since even a minor cut could tear or break the catheter.It also advises, do not stretch the catheter or use alcohol or acetone-based skin preparations, adhesive enhancers, or solutions directly on the catheter.The possible root cause is most likely damage during use caused due to manipulation by the user.This complaint will be used for tracking and trending purposes.

• Brand Name: 5.0FR URETHANE UMB CATH
• Common Device Name: CATHETER, UMBILICAL ARTERY
• Manufacturer (Section D): COVIDIEN; edificio b20 calle #2 zona fra; alajuela ; CS
• MDR Report Key: 9621909
• Report Number: 3009211636-2020-00684
• Device Sequence Number: 2500750
• Product Code: FOS
• UDI-Device Identifier: 20884527005120
• UDI-Public: 20884527005120
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 03/27/2020

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: 8888160341
• Device Catalogue Number: 8888160341
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/21/2020
• Supplement Date Received by Manufacturer: 01/21/2020
• Initial Report FDA Received Date: 01/23/2020
• Supplement Report FDA Received Date: 03/27/2020
• Patient Sequence Number: 1