MAUDE Adverse Event Report: COVIDIEN 3.5FR URETHANE UMB CATH; CATHETER, UMBILICAL ARTERY

Model Number 8888160333

Device Problem Fracture (1260)

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

Event Date 12/14/2018

Event Type  malfunction  

Manufacturer Narrative

The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.

Event Description

The customer reported they found a fracture on a single lumen umbilical arterial catheter.There was no patient harm.

• Brand Name: 3.5FR 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 ; 5084524970
• MDR Report Key: 8254602
• MDR Text Key: 133319367
• Report Number: 3009211636-2019-00634
• 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: other
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8888160333
• Device Catalogue Number: 8888160333
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1