MAUDE Adverse Event Report: COVIDIEN ARGYLE; CATHETER, UMBILICAL ARTERY

Model Number 8888160333

Device Problem Leak/Splash (1354)

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

Event Date 10/01/2017

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.Medwatch# (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

The customer reports that a 3.5 french umbilical vessel catheter was placed in the umbilical artery.After insertion, the catheter was noted to be leaking near the tubing connection.The doctor was notified and the catheter was discontinued.An additional catheter was placed several hours later.

Manufacturer Narrative

Additional information that was received from the customer.An investigation was performed regarding a report of a 3.5 french umbilical catheter placed in the umbilical artery.After insertion, the catheter was noted to be leaking near tubing connection.An additional catheter was placed several hours later.Since no lot number was identified, a manufacturing device history record (dhr) review or product/process changes review for the involved lot number could not be performed.However, all dhrs 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.Consequently, it was not possible to evaluate it as part of a comprehensive failure investigation.No probable cause was found since no sample, picture or video were received for testing, therefore the reported condition is not confirmed.If the sample is returned in the future, this complaint will be re-opened for further investigation.No trends or triggers have been found.Therefore, a corrective or preventive action is not deemed necessary at this time.It must be noted that in-process controls such as personnel training, incoming quality acceptance testing for raw material, 100% in process visual inspection and visual acceptance sampling are performed in the plant) 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.

Event Description

The customer reports that the uvc was noted to be leaking just above the hub where the extension tubing meets the hub.This occurred right after insertion.The customer further reports that betadine was used to clean the skin area and the area was completely dried prior to insertion.It was not difficult to handle the catheter during insertion and it was not difficult to secure.The uvc was secured with suture.The uvc was inserted october 3rd and was in continuous use.The uvc was replaced with the same product.The status of the patient is unknown.

• Brand Name: ARGYLE
• Type of Device: CATHETER, UMBILICAL ARTERY
• Manufacturer (Section D): COVIDIEN; edificio b20, calle #2; alajuela 20101
• Manufacturer (Section G): COVIDIEN; edificio b20, calle #2; alajuela 20101
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 7118361
• MDR Text Key: 94884182
• Report Number: 3009211636-2017-05398
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888160333
• Device Catalogue Number: 8888160333
• Device Lot Number: UNKNWON
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/17/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 1 DA