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Model Number 8888160556
Device Problem Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/24/2017
Event Type  Injury  
Manufacturer Narrative
Submit date: 4/4/2018 a device history review (dhr) revealed no discrepancies that may have contributed to a complaint of this failure 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. One photo was provided by the customer. Visual evaluation of this photo was performed and is not possible confirm occluded with the photo. Additionally, the catheter shows signs of use (remains of blood) inside the plastic bag. The actual sample was received for analysis and investigation. The sample consisted of one dual lumen uvc catheter. The catheter came inside a generic plastic bag. Visual inspection was performed and did not reveal any problem. In order to confirm the reported defect the sample was flushed and the water passed easily through of both lumens. The reported failure has not been confirmed. Based on the available information, it can be concluded that product was manufactured according to specifications and the device functioned as intended for a period of time; therefore the most probable root cause can be considered as misuse; this defect was more likely damaged during use caused due to an inappropriate manipulation by the user. 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: 05/31/17. 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 they had trouble flushing the umbilicus was oozing while port was running. When we started port two, the pump repeatedly alarmed occluded patient side. The umbilical tie was loosened and then attempted to flush port one and it did the same. Previously that night we had trouble with the umbilical artery spraying blood. It did not have a catheter at the time. The artery had to be stitched but was still pulsating. The original uvc was in at 5 cm. The baby was 4500 grams so it is quite possible that between her size and the force of her blood flow, 5 cms just wasn't enough. Another nurse observed what appeared to be a hole in the line.
Manufacturer Narrative
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.
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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 Key6600538
MDR Text Key115229849
Report Number3009211636-2017-05152
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,user f
Reporter Occupation
Remedial Action Inspection
Type of Report Initial,Followup,Followup
Report Date 04/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/31/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8888160556
Device Catalogue Number8888160556
Device Lot Number219803X
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/15/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/02/2017
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 05/31/2017 Patient Sequence Number: 1