• 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 8888160333
Device Problem Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/01/2017
Event Type  malfunction  
Manufacturer Narrative
Additional information that was received from the customer. An investigation was performed regarding a report of a 3. 5 french umbilical catheter placed in the umbilical artery. After insertion, the catheter was noted to be leaking near tubing connection. An additional catheter was placed several hours later. Since no lot number was identified, a manufacturing device history record (dhr) review or product/process changes review for the involved lot number could not be performed. 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 it as part of a comprehensive failure investigation. No probable cause was found since no sample, picture 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. No trends or triggers have been found. 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.
 
Event Description
The customer reports that the uvc was noted to be leaking just above the hub where the extension tubing meets the hub. This occurred right after insertion. The customer further reports that betadine was used to clean the skin area and the area was completely dried prior to insertion. It was not difficult to handle the catheter during insertion and it was not difficult to secure. The uvc was secured with suture. The uvc was inserted october 3rd and was in continuous use. The uvc was replaced with the same product. The status of the patient is unknown.
 
Manufacturer Narrative
An investigation is currently underway. Upon completion, the results will be forwarded. Medwatch# (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
The customer reports that a 3. 5 french umbilical vessel catheter was placed in the umbilical artery. After insertion, the catheter was noted to be leaking near the tubing connection. The doctor was notified and the catheter was discontinued. An additional catheter was placed several hours later.
 
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 20101
Manufacturer (Section G)
COVIDIEN
edificio b20, calle #2
alajuela 20101
Manufacturer Contact
edward almeida
15 hampshire street
mansfield, MA 02048
5084524151
MDR Report Key7118361
MDR Text Key194075513
Report Number3009211636-2017-05398
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 other
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/28/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/14/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8888160333
Device Catalogue Number8888160333
Device Lot NumberUNKNWON
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 Received11/17/2017
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-