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Model Number 8888160333
Device Problem Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/27/2017
Event Type  malfunction  
Manufacturer Narrative
A sample consisting of 2 used uvc catheters were returned for evaluation. The sample came inside a generic plastic bag. During a visual inspection, the used catheters revealed that the samples were manipulated: due to the samples contained remnants of blood. An underwater test was performed and a leak below the strain relief was identified in the catheters, however the origin of the leak could not be observed with a naked eye. Magnified photos were taken and hole below the strain relief was observed. The samples were found with the lot numbers: 163210144 and 1632100151 which had not been previously identified. Based on the available information, it can be concluded that product was manufactured according to specifications and the device functioned as intended for a period of time; therefore the most probable root cause can be considered as unintentional misuse; this condition was most likely damaged during use caused due to incorrect manipulation by the user. 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
Submit date: 3/27/17. An investigation is currently under way; upon completion the results will be forwarded.
Event Description
It was reported to covidien on (b)(6) 2017 that a customer had an issue with a neonatal catheter. The customer reports product has a defect or leak.
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Brand NameARGYLE
Manufacturer (Section D)
edificio b20, calle #2
alajuela 0101
Manufacturer (Section G)
edificio b20, calle #2
alajuela 0101
Manufacturer Contact
edward almeida
15 hampshire street
mansfield, MA 02048
MDR Report Key6437050
MDR Text Key249733320
Report Number3009211636-2017-05048
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,user f
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/28/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/27/2017
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? Device Returned to Manufacturer
Date Returned to Manufacturer03/07/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/27/2017
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown