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Model Number 8888160531
Device Problem Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
A device history record review could not be performed because a lot number was not received with the complaint. As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product. Because a sample was not returned, we were unable to perform a thorough follow up investigation to include functional and visual evaluations to confirm the reported issue and root cause analysis. Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures. If additional information is obtained, or the sample is returned, this file will be re-opened for further investigation. As no trends or triggers have been found a corrective and/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 facility. This complaint will be used for qa tracking and trending purposes. If information is provided in the future, a supplemental report will be issued.
Manufacturer Narrative
Submit date: (b)(6) 2017. An investigation is currently underway. Upon completion, the results will be forwarded.
Event Description
The customer reports that a 3. 5 double lumen umbilical vessel catheter (uvc) broke during use when infusing iv fluids and iv nutrition. There was slow oozing from the cracked portion of the line and persisted for 36 hours before it was noted that the uvc was cracked when a manual flush of the line was attempted. The customer further reports that this placed the baby at increased risk of infection. The baby needed to be poked unnecessarily for an iv.
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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 Key6777384
MDR Text Key195839761
Report Number3009211636-2017-05258
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 02/05/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/09/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8888160531
Device Catalogue Number8888160531
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 Received08/02/2017
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