MAUDE Adverse Event Report: COVIDIEN ARGYLE CATHETER, UMBILICAL ARTERY

Model Number 8888160341

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/06/2017

Event Type  malfunction  

Manufacturer Narrative

The returned sample consisted in 1 used uvc catheter. The sample came inside a generic plastic bag. During visual inspection, the sample revealed sign of use (rest of blood). Under water test was performed and a leak below the strain relief could be identified in the catheter, however the origin of the leak could not be observed with a naked eye. A magnified picture was taken and the sample revealed a cut below the strain relief. The complaint sample investigation concluded that this is not related to the manufacturing process.

Event Description

The customer reports leaking occurred where catheter joins hub. Catheter was not clamped in this location per clinician. The uvc was removed and replaced with another one.

• Brand Name: ARGYLE
• Type of Device: CATHETER, UMBILICAL ARTERY
• Manufacturer (Section D): COVIDIEN; edificio b20, calle #2; alajuela 0101
• Manufacturer (Section G): COVIDIEN; edificio b20, calle #2; alajuela 0101
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6567881
• MDR Text Key: 75210754
• Report Number: 3009211636-2017-05109
• 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: company representative,user f

Reporter Occupation

• Type of Report: Initial
• Report Date: 04/06/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 05/15/2017
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2017

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown