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

Model Number 8888160341

Device Problems Fluid/Blood Leak (1250); Migration (4003)

Patient Problem No Information (3190)

Event Date 07/12/2019

Event Type  malfunction  

Manufacturer Narrative

A device history record review could not be performed because a lot number was not received with the complaint.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.Samples were not received for the investigation.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the defect and root cause analysis.If a sample is returned; this complaint will be reopened.A corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.This complaint will be used for qa tracking and trending purposes.

Event Description

The customer stated that the catheter is too soft and bends on insertion and moves out of place (migrates).The customer further stated that during one incident the catheter leaked into the abdomen.No additional incident details were able to be provided by the customer.

• 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
• Manufacturer (Section G): COVIDIEN; edificio b20 calle #2 zona fra; alajuela ; CS
• Manufacturer Contact: jill saraiva ; 15 hampshire street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 8890771
• MDR Text Key: 163306428
• Report Number: 3009211636-2019-00666
• Device Sequence Number: 1
• Product Code: FOS
• UDI-Device Identifier: 20884527005120
• UDI-Public: 20884527005120
• Combination Product (y/n): N
• Reporter Country Code: SF
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2019
• 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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/15/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1