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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 8888160531
Device Problem Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/03/2017
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Submit date: 07/23/2018. The complaint description states that [the customer reports umbilical lines placed to uac/uvc. After fluids started, the uac catheter was noted to have a small hole in the catheter which blood was backing up in and leaking out. The uac was removed and replaced with a new catheter. ] as no lot number was identified, a manufacturing device history review (dhr) or product/process changes review for the involved lot number could not be performed. However, all dhr¿s 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. Since no sample was returned for examination, it was not possible to evaluate as part of a comprehensive failure investigation. If the sample is returned in the future, this complaint will be re-opened for further investigation. The available information was analyzed and did not confirm a root cause for the event. However, device history reports were reviewed in order to identify the possible causes for the failure: leaking. The following potential causes were identified: machine malfunction, customer misuse, inspection in process failed or not performed, defective material, sharps usage with catheter. It must be noted that in-process controls are in place to prevent nonconforming product from leaving the manufacturing operations. This complaint was unable to be confirmed. A root cause could not be determined. 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. Medwatch report no: (b)(4).
 
Event Description
The customer reports umbilical lines placed to uac/uvc. After fluids started, the uac catheter was noted to have a small hole in the catheter which blood was backing up in and leaking out. The uac was removed and replaced with a new catheter.
 
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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 Key6523364
MDR Text Key246428680
Report Number3009211636-2017-05095
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,Followup,Followup
Report Date 10/03/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/26/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8888160531
Device Catalogue Number8888160531
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/08/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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