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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 10/28/2017
Event Type  malfunction  
Manufacturer Narrative
The reported lot number was invalid therefore 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 there were no samples, pictures or video 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 root cases are: 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 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 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
Submit date: 11/13/2017. 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 reported while wanting to replace the stopcock on the catheter, the nurse was kinking the catch in order to prevent blood loss from the catheter and preventing air coming in. While finishing the procedure, the nurse noticed a leak where the kink was done, near the proximal end.
 
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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 Key7025934
MDR Text Key253308987
Report Number3009211636-2017-05347
Device Sequence Number1
Product Code FOS
Combination Product (y/n)N
Reporter Country CodeIS
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 02/21/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/13/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8888160333
Device Catalogue Number8888160333
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 Received10/30/2017
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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