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

Model Number 8888160341

Device Problem Fluid Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/11/2020

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

Customer reports that the device malfunctioned during use on a premature newborn baby. The device was working but "has stopped reading well" due to a leakage. On 1/8/2021 additional information states: the uac stopped reading well, so the line was inspected. Blood was noted to be backing up into catheter so all clamps were checked and verified fluid was infusing. The uac was flushed and noted there was a leak in the line where it connects to the hub. The uac was clamped below the leak, but per md had to be left in until off the ecmo circuit, which wasn't cut away until the end of the shift. This resulted in the loss of an arterial line for an ecmo trial and cut away, and left no drawable lines for gases resulting in pokes of a heparinized infant.

• 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: 11143328
• MDR Text Key: 226030823
• Report Number: 3009211636-2021-00732
• Device Sequence Number: 1
• Product Code: FOS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 03/15/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 01/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 8888160341
• Device Catalogue Number: 8888160341
• Was Device Available for Evaluation?: Yes

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage