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Model Number 8888160333
Device Problem Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/20/2017
Event Type  malfunction  
Manufacturer Narrative
A device history record (dhr) review of the reported lot number confirmed that the product was produced accomplishing quality requirements and released according to established procedures. Sample received consisted in two uvc catheters, which came inside a generic plastic bag. One of the samples presents signs of use (remains of blood) and the other catheter returned closed. Under water test was performed and a leak below the strain relief could be identified in the used catheter. Magnified pictures were taken and in the sample a hole/tear was observed. Based on all gathered information, the most probable root cause for this event can be considered as costumer misuse. 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. If information is provided in the future, a supplemental report will be issued.
Manufacturer Narrative
Submit date: 08/22/2017. An investigation is currently underway. 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 an issue with an umbilical vessel catheter (uvc). A small drop of blood was noted near the connection at end, a scant amount. Aiv asp when trying to aspirate blood from the uvc. Tried to flush, but the leak was noted near the connection (crack noted in uvc). There was no patient injury.
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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 Key6812104
MDR Text Key251287496
Report Number3009211636-2017-05267
Device Sequence Number1
Product Code FOS
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/25/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/22/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/27/2021
Device Model Number8888160333
Device Catalogue Number8888160333
Device Lot Number1630000180
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/25/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/25/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/27/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown