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Model Number 8888160341
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. A sample was not returned for evaluation; however, one photo was provided by the customer. Visual evaluation of this photo was performed and it showed the umbilical vessel catheter (uvc) resting on a table. In addition, it was observed that the catheter showed signs of use (remains of blood) and the tubing was cracked below the strain relief. The reported issue was confirmed. A potential root cause identified, is customer misuse (excessive force, inappropriate use of cleaning agents, sharp objects, etc. ). It is possible that the catheter was damaged by instruments with sharp or rough edges during clinical use, resulting in a cracked catheter. Additionally, the catheter was in use for an undetermined amount of time without issues. It is important to consider that the instructions for use warn: ¿exercise caution when using sharp instruments near the catheter. Do not use instruments with sharp or rough edges directly on the catheter since even a minor cut could tear or break the catheter. Do not pinch or bend the catheter back to temporarily occlude the catheter. This causes increased stress on the catheter which can lead to a leak or break¿ and continues, ¿do not use alcohol, acetone, or alcohol containing antiseptics directly on the catheter. Carefully check antiseptic solutions for alcohol or acetone. These substances may cause irreversible damage to the polyurethane which can lead to a leak or break. Ensure gloves or other surfaces which have alcohol on them are completely dry before touching or manipulating the catheter¿. This issue would be identified during assembly operations as manufacturing performs 100% pressure testing during production. Per the event description, the catheter was cleaned with alcohol. 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 in place to prevent nonconforming product from leaving the manufacturing facility. 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: 08/09/2017. 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 that 5fr single lumen umbilical vessel catheter (uvc) was inserted as an arterial catheter. The line cracked immediately following the insertion procedure which required the line to be removed and a new arterial catheter to be inserted.
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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 Key6778526
MDR Text Key258440928
Report Number3009211636-2017-05260
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 Number8888160341
Device Catalogue Number8888160341
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