MAUDE Adverse Event Report: COVIDIEN ARGYLE CATHETER, UMBILICAL ARTERY

Model Number 8888160531

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/23/2017

Event Type  malfunction  

Manufacturer Narrative

There was no lot number provided therefore, a manufacturing device history record (dhr) review or product/process change review for the involved lot number could not be reviewed. 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 product for the reported condition as part of a comprehensive failure investigation. No probable cause was found since no sample, picture¿s 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. Potential failure could occur during normal use if there is a leak at the strain relief junction however manufacturing performs a 100% leak testing as per procedure which would identify this issue during the catheter assembly. No trends or triggers have been identified 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.

Manufacturer Narrative

Added sample evaluation for sample received after filing the supplemental report. Summary of evaluation as follows: manufacturing performs 100% leak testing as per procedure which would identify this issue during the catheter assembly process. Based on the sample evaluation it appears that the catheter had a hole below the strain relief and 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. 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. 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 as described in the ifu. A complaint history analysis from sep 2016 to aug 2017 was conducted. 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. If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

An investigation is currently under way; upon completion the results will be forwarded. If information is provided in the future, a supplemental report will be issued.

Event Description

The customer reports that they flushed the uvc line in preparation for a medication. Line began to leak from a small hole ~ 9 cm mark. The uvc was removed and replaced.

• 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: 7224283
• MDR Text Key: 194264031
• Report Number: 3009211636-2018-00029
• Device Sequence Number: 1
• Product Code: FOS
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 03/26/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 01/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 8888160531
• Device Catalogue Number: 8888160531
• 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: 01/02/2018
• 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