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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN ARGYLE CATHETER, UMBILICAL ARTERY

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COVIDIEN ARGYLE CATHETER, UMBILICAL ARTERY Back to Search Results
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.
 
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Brand NameARGYLE
Type of DeviceCATHETER, 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 Key6744443
MDR Text Key262148379
Report Number3009211636-2017-05237
Device Sequence Number1
Product Code FOS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Received07/26/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/22/2021
Device Model Number8888160333
Device Catalogue Number8888160333
Device Lot Number1620200114
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 Received06/28/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/22/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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