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Model Number 8888160341
Device Problem Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The lot number was provided and the device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards. 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. Manufacturing performs 100% leak testing as per procedure, which would identify this issue in the catheter assembly. No trends or triggers have been found; therefore, a corrective and 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. If additional information is obtained, or the sample is returned, this file will be re-opened for further investigation. This complaint will be used for qa tracking and trending purposes. If information is provided in the future, a supplemental report will be issued.
Event Description
The customer reported that while caring for the pre-term infant, the registered nurse (rn) noted the umbilical venous catheter (uvc) that was in place had a hole in the catheter. The rn stated that she was checking in on the infant when she noticed that the diaper went wet. Upon closer examination, she noticed fluid leaking from a hole in the line. The hole was located near the umbilical site, about 1/2cm from the umbilical. The line had been pulled back 3 cm about 30 minutes prior. The customer further reports that there were no clamps in use at the time and the rn stated that the catheter was not kinked. The neonatal nurse practitioner was alerted to the issue, and the catheter was removed. The premature infant was in the nicu, in an isolette on respiratory support. Was no harm determined in review of the event.
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Manufacturer Narrative
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 Key7336861
MDR Text Key102336226
Report Number3009211636-2018-00070
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 other
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 07/30/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/13/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/10/2022
Device Model Number8888160341
Device Catalogue Number8888160341
Device Lot Number1713000079
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 Received02/13/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/10/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown