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Model Number 8888160325
Device Problem Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/05/2017
Event Type  malfunction  
Manufacturer Narrative
A devices history record (dhr) review revealed no discrepancies that may have contributed to a complaint of this type of condition. 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 dhr are reviewed for accuracy prior to product release. The product sample was received for analysis and investigation; it consisted in one unused uvc catheter, which came inside a pouch in a generic plastic bag. Visually the catheter did not show a defect. Under water testing was performed and there was no leak observed in the catheter. The sample evaluation revealed that the reported condition could not be confirmed. Based on this information the most probable cause was that the clinician confused blood residue with leaking. Blood residues could be caused by the treatment or other condition in the patient. With the available information this is the most possible root cause for this event. Additionally based on the event description, the condition was noticed during use, after priming the catheter. Based on the available information, it can be concluded that product was manufactured according to specifications and the device functioned as intended for an undetermined amount of time; therefore the most probable root cause can be considered as customer perception (blood residues were confused with leaking). There are no trends or triggers found for the reported condition, therefore, a corrective or preventive action is not deemed necessary 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: 8/1/17. 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 reports that the catheter slot cracked and leaked during ongoing therapy.
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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 Key6757987
MDR Text Key262149496
Report Number3009211636-2017-05245
Device Sequence Number1
Product Code FOS
Combination Product (y/n)N
Reporter Country CodeIT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/23/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/01/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/26/2016
Device Model Number8888160325
Device Catalogue Number8888160325
Device Lot Number1506800117
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/03/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/07/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown