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

Model Number 8888160341

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/06/2019

Event Type  malfunction  

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 Description

The customer reports when they began infusing through a newly inserted umbilical venous catheter, it was noted to have blood backing up in the line and a bubble of fluid leaking at the most proximal edge of the joint where the tubing meets the hub.

Manufacturer Narrative

A lot number was not provided therefore a device history record (dhr) review could not be performed.All dhr¿s are reviewed for accuracy prior to releasing the product.A sample consisting of one uvc catheter was returned for evaluation.The catheter showed signs of use; more specifically traces of blood.A visual inspection found that the catheter had a leak below the strain relief junction which may occur during normal use.Manufacturing performs a 100% leak test which would identify this issue during the catheter assembly process.Based on the available information, it can be concluded that product was manufactured according to specifications and the device functioned as intended for an undetermined amount of time; therefore the most probable root cause can be attributed to unintentional damage during use when the user manipulates the device.No trends or triggers have been found, therefore, a corrective or preventive action is not deemed necessary at this time.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 according to product specification are in place to prevent nonconforming product from leaving the manufacturing operations.This complaint will be used for tracking and trending purposes.

• Brand Name: 5.0FR URETHANE UMB CATH
• Type of Device: CATHETER, UMBILICAL ARTERY
• Manufacturer (Section D): COVIDIEN; edificio b20 calle #2 zona fra; alajuela ; CS
• MDR Report Key: 8323333
• MDR Text Key: 135693348
• Report Number: 3009211636-2019-00640
• Device Sequence Number: 1
• Product Code: FOS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 05/16/2019

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
• Device Operator: No Information
• Device Model Number: 8888160341
• Device Catalogue Number: 8888160341
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/06/2019
• Initial Date FDA Received: 02/08/2019
• Supplement Dates Manufacturer Received: 02/06/2019
• Supplement Dates FDA Received: 05/16/2019
• Patient Sequence Number: 1