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Model Number 8888160333
Device Problem Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/04/2016
Event Type  malfunction  
Manufacturer Narrative
The actual sample involved in the reported incident was not returned for evaluations. No additional information, pictures or videos were received. Since no sample was returned for examination, it was not possible to evaluate it as part of a comprehensive failure investigation. As no lot number was identified, a manufacturing device history review or product/process changes review for the involved lot number could not be performed. However, all device history records (dhr)s are reviewed for accuracy prior to product release. If the sample is returned in the future, this complaint will be re-opened for further investigation. The products specifications were reviewed in order to identify the possible causes for the deficiency reported; leaking. The following potential causes were identified in the pfmea/dfmea or in addition to this document: unintentional customer misuse if an inspection in process failed or was not performed to identify defective material when using a sharp instrument near or with a catheter. 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
Submit date: 05/19/2017. 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 a uvc (umbilical vessel catheter) was placed. Right after placement the uvc was leaking just below the hub where the catheter is joined. The uvc was clamped and discontinued. The customer further reported that alcohol is used to clean only the actual hub.
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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 Key6577838
MDR Text Key250607814
Report Number3009211636-2017-05111
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,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/26/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/19/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8888160333
Device Catalogue Number8888160333
Device Lot NumberUNKNOWN
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 Received04/27/2017
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown