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Model Number 8888160341
Device Problem Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/30/2017
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Manufacturer Narrative
An investigation of the reported condition was performed. A device history review revealed no discrepancies that may have contributed to a complaint of this issue. All quality assurance testing performed during manufacturing was acceptable. The quality assurance review of the visual, physical and dimensional evaluation results indicated that the product met specification requirements. In addition, all device history record (dhr) are reviewed for accuracy prior to product release. One used uvc catheter sample was received for testing and investigation. The sample presents a residue of blood inside the tubing. Additionally the sample was returned inside a generic bag. Under water testing was performed and a leak below the strain relief could be identified in the catheter. However the origin of the leak could not be observed with a naked eye. A magnified picture was taken and clean cut below the strain relief was observed. The device history record (dhr) was reviewed and no deviations related to this issue mode were found. The product sample was returned to the manufacturing site for evaluation. Based on the evaluation and available information, it can be concluded that product was manufactured according to specifications; therefore the most probable root cause can be considered as unintentional misuse; this product was most likely damaged during use caused due to inappropriate manipulation by the user. No harm was report by this complaint, and therefore no corrective or preventive actions are required at this time. 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: 6/23/17. An investigation is currently under way; upon completion the results will be forwarded. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
Event Description
The customer reported the uvc was in the patient and the nurse noticed a crack and leaking.
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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 Key6664473
MDR Text Key246429804
Report Number3009211636-2017-05206
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,Followup
Report Date 01/08/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/23/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8888160341
Device Catalogue Number8888160341
Device Lot Number1628700151
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/02/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/30/2017
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