MAUDE Adverse Event Report: COVIDIEN MANUFACTURING SOLUTIONS SA ARGYLE CATHETER, UMBILICAL ARTERY

Model Number 8888160531

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/03/2017

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Submit date: 5/23/2018, as no lot number was identified, a manufacturing device history review or product/process changes review for the involved lot number could not be performed. However, all device history reports (dhr) are reviewed for accuracy prior to product release. The sample received consisted of one used uvc catheter. The sample came inside a generic plastic bag. During testing, a leak below the strain relief was confirmed within the catheter. However, the origin of the leak could not be identified. Magnified picture was taken and tear below the strain relief was observed. It appears the operator did not follow protocol and/or inspection procedures. The cut reported would have been detected prior to use. The issue was noticed during use. The reported issue has been confirmed. The product sample was returned to the manufacturing site for review. Based on the available information, it can be concluded that product was manufactured according to specifications. Therefore, the most probable root cause can be considered as misuse; this issue was most likely damaged during use caused due to an inappropriate manipulation by the user. It must be noted that in-process controls are in place to prevent nonconforming product from leaving the manufacturing operations. This complaint will be used for tracking and trending purposes. If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

An investigation is currently underway. Upon completion, the results will be forwarded.

Event Description

The customer reports the catheter was leaking at the hub. The customer further reports that there was no patient injury as a result of the incident.

• Brand Name: ARGYLE
• Type of Device: CATHETER, UMBILICAL ARTERY
• Manufacturer (Section D): COVIDIEN MANUFACTURING SOLUTIONS SA; edificio 820 calle #2; zona france coyol; alajuela,cr 20101
• Manufacturer (Section G): COVIDIEN MANUFACTURING SOLUTIONS SA; edificio 820 calle #2; zona france coyol; alajuela,cr 20101
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6563435
• MDR Text Key: 246296668
• Report Number: 3009211636-2017-05106
• 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,health

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 05/23/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 05/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 8888160531
• Device Catalogue Number: 8888160531
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/02/2017
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Unkown