MAUDE Adverse Event Report: COVIDIEN ARGYLE CATHETER, UMBILICAL ARTERY

Model Number 8888160531

Device Problem Leak/Splash (1354)

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

Event Date 03/03/2017

Event Type  malfunction  

Manufacturer Narrative

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

Manufacturer Narrative

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

Manufacturer Narrative

Submit date: 07/23/2018. The complaint description states that [the customer reports umbilical lines placed to uac/uvc. After fluids started, the uac catheter was noted to have a small hole in the catheter which blood was backing up in and leaking out. The uac was removed and replaced with a new catheter. ] as no lot number was identified, a manufacturing device history review (dhr) or product/process changes review for the involved lot number could not be performed. However, all dhr¿s are reviewed for accuracy prior to product release. The actual sample involved in the reported incident was not returned for evaluation. No additional information, pictures or videos were received. Since no sample was returned for examination, it was not possible to evaluate as part of a comprehensive failure investigation. If the sample is returned in the future, this complaint will be re-opened for further investigation. The available information was analyzed and did not confirm a root cause for the event. However, device history reports were reviewed in order to identify the possible causes for the failure: leaking. The following potential causes were identified: machine malfunction, customer misuse, inspection in process failed or not performed, defective material, sharps usage with catheter. It must be noted that in-process controls are in place to prevent nonconforming product from leaving the manufacturing operations. This complaint was unable to be confirmed. A root cause could not be determined. 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. Medwatch report no: (b)(4).

Event Description

The customer reports umbilical lines placed to uac/uvc. After fluids started, the uac catheter was noted to have a small hole in the catheter which blood was backing up in and leaking out. The uac was removed and replaced with a new catheter.

• 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: 6523364
• MDR Text Key: 246428680
• Report Number: 3009211636-2017-05095
• 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

• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/03/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/26/2017
• 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?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Unkown