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

Model Number 8888160333

Device Problem Material Perforation (2205)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/07/2018

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.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.

Event Description

The customer states after insertion it was observed that the catheter was perforated.Additional information was requested however no further details could be provided.

• 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
• MDR Report Key: 8228394
• MDR Text Key: 132497421
• Report Number: 3009211636-2019-00631
• Device Sequence Number: 1
• Product Code: FOS
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2019
• 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
• Device Lot Number: 1606900100
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/02/2019
• 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