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Model Number 8888160341
Device Problem Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/31/2018
Event Type  malfunction  
Manufacturer Narrative
Submit date: 2/27/2018. The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event. As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product. If additional information or the sample is received, the investigation will be reopened and responded to accordingly. If information is provided in the future, a supplemental report will be issued.
Event Description
The customer reports a leak had been found on the catheter.
Manufacturer Narrative
An investigation of the reported condition was performed. A device history record (dhr) review revealed no discrepancies that may have contributed to a complaint of this issue mode. 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 actual sample involved in the reported incident was not returned for evaluation. No additional information, pictures or videos were received. Consequently, it was not possible to evaluate it as part of a comprehensive investigation. No probable cause was found since no sample, picture or video were received for testing. Therefore, the issue was not confirmed. If the sample is returned in the future, this complaint will be re-opened for further investigation. The line contains leakage as a potential issue. However, manufacturing performs 100% leak testing as per procedure, which would identify this issue in the catheter assembly. None of the complaints have been confirmed as manufacturing related issues. No trends or triggers have been found. 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 performed in the plant) 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
Sample evaluation for sample received after the supplemental filing. The sample consisted of one used uvc catheter, which came inside a generic plastic bag. The sample presents signs of use (remains of blood). Under water testing was performed and a leak below the strain relief could be identified in the catheter. Magnified pictures were taken and a tear/hole was observed in the catheter. If information is provided in the future, a supplemental report will be issued.
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Brand NameARGYLE
Manufacturer (Section D)
edificio b20, calle #2
alajuela 20101
Manufacturer (Section G)
edificio b20, calle #2
alajuela 20101
Manufacturer Contact
edward almeida
15 hampshire street
mansfield, MA 02048
MDR Report Key7300858
MDR Text Key101170813
Report Number3009211636-2018-00067
Device Sequence Number1
Product Code FOS
Combination Product (y/n)N
Reporter Country CodeIS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/26/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/27/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/22/2021
Device Model Number8888160341
Device Catalogue Number8888160341
Device Lot Number1626500197
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 Received02/05/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/22/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial