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Model Number 8888160531
Device Problem Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/06/2017
Event Type  malfunction  
Manufacturer Narrative
There was no lot number identified therefore a manufacturing device history record (dhr) review or product/process changes review for the involved lot number could not be performed. All dhrs are reviewed for accuracy prior to product release. A product sample consisted of one used uvc catheter, which came inside a generic plastic bag. The sample shows signs of use; remains of blood. Under water testing was performed and a leak below the strain relief was identified in the catheter. Magnified pictures were taken and in the sample a tear/hole was observed. Manufacturing performs a100% leak testing as per procedure which would identify this issue during the catheter assembly. Based on the available information, it can be concluded that the product was manufactured according to specifications; therefore the most probable root cause can be considered as unintentional misuse most likely damaged during use by manipulation or a sharp object being used. 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 purpose. If information is provided in the future, a supplemental report will be issued.
Manufacturer Narrative
Submit date: 11/8/2017. 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 states that a leak occurred after a nurse pinched off the catheter to change fluids. The leak occurred just below the hub/butterfly where the device was joined. The patient was not impacted.
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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 edward
15 hampshire street
mansfield, MA 02048
MDR Report Key7010636
MDR Text Key252249731
Report Number3009211636-2017-05343
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/20/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/08/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8888160531
Device Catalogue Number8888160531
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 Received10/23/2017
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