MAUDE Adverse Event Report: COVIDIEN ARGYLE CATHETER, UMBILICAL ARTERY

Model Number 8888160333

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/28/2017

Event Type  malfunction  

Manufacturer Narrative

A device history review (dhr) revealed no discrepancies that may have contributed to a complaint of this reported condition. All quality assurance testing performed during manufacturing was acceptable. The quality assurance review of the visual, physical and dimensional evaluation results indicated that the product met specification requirements. In addition, all dhr are reviewed for accuracy prior to product release. One used uvc catheter was received for testing and investigation. The sample presents blood residue inside the tubing; additionally the sample was placed inside a generic bag. Under water testing was performed and a leak below the strain relief could be identified in the catheter. A magnified picture was taken and clean tear below the strain relief was observed. The uvc catheter showed signs of being used in a patient. It is important to consider that the instructions for use warn: exercise caution when using sharp instruments near the catheter. Do not use instruments with sharp or rough edges directly on the catheter since even a minor cut could tear or break the catheter. Do not pinch or bend the catheter back to temporarily occlude the catheter. This causes increased stress on the catheter which can lead to a leak or break. Do not use clamps on umbilical vessel catheters] and continues; do not use alcohol, acetone, or alcohol containing antiseptics directly on the catheter. Carefully check antiseptic solutions for alcohol or acetone. These substances may cause irreversible damage to the polyurethane which can lead to a leak or break. Ensure gloves or other surfaces which have alcohol on them are completely dry before touching or manipulating the catheter. In addition the ifu states: the catheter lumen or catheter shaft should be flushed and filled with heparinized saline per hospital protocol. The catheter may be grasped with a smooth forceps or fingertips and inserted into the lumen of the dilated vessel. Catheter lumen should be occluded with saline via intermittent infusion caps or luer-lock syringes during insertion to avoid air emboli]. Based on the available information this potential cause could not be discarded. 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 unintentional misuse; this condition was most likely damaged during use caused due to inappropriate manipulation by the user. There were no complaint triggers or trends identified, no harm was report by this complaint, and therefore no corrective or preventive actions are required. 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 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

Submit date: 7/26/17. An investigation is currently under way; upon completion the results will be forwarded.

Event Description

The customer reports catheter was used on a nicu baby. It was inserted and during use the catheter line leaked. The line had to be removed (stopping arterial line and bp assessments) while it was replaced.

• 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: 6744443
• MDR Text Key: 262148379
• Report Number: 3009211636-2017-05237
• 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,Followup
• Report Date: 01/11/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 07/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 06/22/2021
• Device Model Number: 8888160333
• Device Catalogue Number: 8888160333
• Device Lot Number: 1620200114
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2016
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Unkown