MAUDE Adverse Event Report: COVIDIEN 5FR DUAL-LUMEN UVC CATH; CATHETER, UMBILICAL ARTERY

Model Number	8888160556
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/09/2018
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 nurse practitioner was adjusting placement of an umbilical venous catheter and noticed that there was a drop of iv fluid escaping from the side of the umbilical catheter.The point where the fluid was leaking was close to where the line was sutured; the nurse practitioner noticed that the suture was quite tight.
Additional Manufacturer Narrative
H 3: evaluation summary: because no lot number was available, 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 presented signs of use.During the evaluation the catheter showed a leak below the strain relief.An underwater test was performed and a leak below the strain relief could be identified on the catheter.The reported condition has been confirmed.The most probable root cause can be considered as the catheter was most likely damage during use due to a sharp instrument or manipulation.It must be noted that in-process controls, such as personnel training, incoming quality acceptance testing for raw material, 100% in process visual inspection and visual acceptance sampling, are in place to prevent nonconforming product from leaving the manufacturing operations.This complaint will be used for tracking and trending purposes.

• Brand Name: 5FR DUAL-LUMEN UVC CATH
• Common Device Name: CATHETER, UMBILICAL ARTERY
• Manufacturer (Section D): COVIDIEN; edificio b20 calle #2 zona fra; alajuela ; CS
• MDR Report Key: 9660891
• Report Number: 3009211636-2020-00685
• Device Sequence Number: 11631672
• Product Code: FOS
• UDI-Device Identifier: 20884527005182
• UDI-Public: 20884527005182
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2020

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: 8888160556
• Device Catalogue Number: 8888160556
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/29/2020
• Supplement Date Received by Manufacturer: 01/29/2020
• Initial Report FDA Received Date: 02/03/2020
• Supplement Report FDA Received Date: 04/03/2020
• Patient Sequence Number: 1