• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN ARGYLE CATHETER, UMBILICAL ARTERY

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

COVIDIEN ARGYLE CATHETER, UMBILICAL ARTERY Back to Search Results
Model Number 8888160358
Device Problem Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/14/2017
Event Type  malfunction  
Manufacturer Narrative
A device history record (dhr) review 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. A sample consisting of one used uvc catheter, which came inside a generic plastic bag was returned for evaluation. The sample shows signs of use; remains of blood. Under water testing was performed and a leak below the strain relief was identified in the catheter. Magnified pictures were taken and a tear/hole was observed. Based on the fishbone diagram, the possible causes were identified as: machine malfunction, unintentional customer misuse, product inspection inadequacy or not performed, or a sharp object was used that came into contact with the catheter are all possibilities. Sharp objects should not be used with a catheter. 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. There are a number of alternatives on the field like exposure to chemical agents, proximity to heat sources or manipulation per se, that may lead to tubing tear. Moreover, the condition found in this sample caused a leak which would be identified during assembly operations, since manufacturing performs 100% pressure testing during production. 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; most likely damaged during use caused due to manipulation by the user. No complaint triggers or trends were identified and no harm was report in 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
An investigation is currently underway. Upon completion, the results will be forwarded.
 
Event Description
The customer reports that after 8 days, leakage was observed at the proximal end of the umbilical vessel catheter (uvc). The uvc was replaced immediately. The customer further reports that there was no patient injury.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key7084190
MDR Text Key253208545
Report Number3009211636-2017-05374
Device Sequence Number1
Product Code FOS
Combination Product (y/n)N
Reporter Country CodeHK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/23/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/05/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/27/2020
Device Model Number8888160358
Device Catalogue Number8888160358
Device Lot Number1523900128
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 Received11/14/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/27/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

-
-