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U.S. Department of Health and Human Services


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Model Number 8888160341
Device Problem Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The product related to this complaint is product code: 8888160341, product description: 5. 0fr p u r umbil cath x10, lot number 1606300162. A sample consisted in 1 used uvc catheter and 10 closed packages were received for evaluation. The sample came inside a generic plastic bag. During a visual inspection, the used catheter revealed that the sample was manipulated: due to the sample presents remains of blood. Under water testing was performed and a leak below the strain relief could be identified in the catheter, however the origin of the leak could not be observed with a naked eye. A magnified picture was taken and hole below the strain relief was observed. In order to confirm the reported defect, the closed packages were open and were submitted to under water test and as a result it did not show any leakage or defect. It is important to consider that the instructions for use warnings are: 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. 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: 3/8/17. An investigation is currently under way; upon completion the results will be forwarded.
Event Description
It was reported to covidien on( b)(6) 2017 that a customer had an issue with an umbilical vessel catheter (uvc). The catheter section of the uvc split open. The catheter was pulled and a new one was replaced. No patient injury or complications.
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Brand NameARGYLE
Manufacturer (Section D)
covidien manufacturing solulfo
edificio 820 calle #2 zona fra
alajuela,cr 20101
Manufacturer (Section G)
covidien manufacturing solulfo
edificio 820 calle #2 zona fra
alajuela,cr 20101
Manufacturer Contact
edward almeida
15 hampshire street
mansfield, MA 02048
MDR Report Key6390260
MDR Text Key249669927
Report Number3009211636-2017-05026
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 user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/21/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/08/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/03/2021
Device Model Number8888160341
Device Catalogue Number8888160341
Device Lot Number1606300162
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/21/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/10/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/03/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial