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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN MANUFACTURING SOLUTIONS SA ARGYLE CATHETER, UMBILICAL ARTERY

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COVIDIEN MANUFACTURING SOLUTIONS SA ARGYLE CATHETER, UMBILICAL ARTERY Back to Search Results
Model Number 8888160531
Device Problem Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/03/2017
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Submit date: 5/23/2018, as no lot number was identified, a manufacturing device history review or product/process changes review for the involved lot number could not be performed. However, all device history reports (dhr) are reviewed for accuracy prior to product release. The sample received consisted of one used uvc catheter. The sample came inside a generic plastic bag. During testing, a leak below the strain relief was confirmed within the catheter. However, the origin of the leak could not be identified. Magnified picture was taken and tear below the strain relief was observed. It appears the operator did not follow protocol and/or inspection procedures. The cut reported would have been detected prior to use. The issue was noticed during use. The reported issue has been confirmed. The product sample was returned to the manufacturing site for review. 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 misuse; this issue was most likely damaged during use caused due to an inappropriate manipulation by the user. It must be noted that in-process controls 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 the catheter was leaking at the hub. The customer further reports that there was no patient injury as a result of the incident.
 
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Brand NameARGYLE
Type of DeviceCATHETER, UMBILICAL ARTERY
Manufacturer (Section D)
COVIDIEN MANUFACTURING SOLUTIONS SA
edificio 820 calle #2
zona france coyol
alajuela,cr 20101
Manufacturer (Section G)
COVIDIEN MANUFACTURING SOLUTIONS SA
edificio 820 calle #2
zona france coyol
alajuela,cr 20101
Manufacturer Contact
edward almeida
15 hampshire street
mansfield, MA 02048
5084524151
MDR Report Key6563435
MDR Text Key246296668
Report Number3009211636-2017-05106
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 company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/23/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/12/2017
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? Yes
Date Returned to Manufacturer05/02/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/08/2017
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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