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Model Number 8888160341
Device Problem Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/09/2017
Event Type  malfunction  
Manufacturer Narrative
Submit date: on (b)(6) 2017 this complaint was investigated and according to the event description, the customer stated they had pinched off the umbilical catheter while disconnecting and reconnecting the tubing so the line would not back up and a leak was noticed at the site of the bend. 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 dhrs are reviewed for accuracy prior to product release. One used umbilical vessel catheter (uvc) was received inside a generic plastic bag. During visual inspection, the catheter revealed that the sample was manipulated. The sample was received with one clearlink, one stopcock and a syringe. An underwater test was performed and the reported issue was confirmed; a leak below the strain relief could be identified in the catheter. However, the origin of the leak could not be observed with a naked eye. A magnified picture was taken and hole below the strain relief was observed. Through sample evaluation, it was observed that the catheter presented a hole below the strain relief, the uvc catheter showed signs of being used in a patient. 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. Do not use clamps on umbilical vessel catheters 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. In addition the ifu states the catheter lumen or catheter shaft should be flushed and filled with heparinized saline per hospital protocol. The catheter may be grasped with a smooth forceps or fingertips and inserted into the lumen of the dilated vessel. Catheter lumen should be occluded with saline via intermittent infusion caps or luer-lock syringes during insertion to avoid air emboli. Based on the available information, it can be concluded that product was manufactured according to specifications; therefore, the most probable root cause can be considered as misuse; this issue was most likely damaged during use, due to 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: 3/9/2017 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 states they had pinched off the umbilical catheter while disconnecting and reconnecting tubing so the line would not back up and a leak was noticed at the site of the bend. Because of the issue, the catheter was pulled and replaced with a new one. The patient (infant) had a peripheral iv placed and multiple picc attempts (peripherally inserted central catheter). Betadine was used to clean the skin prior to insertion. Patient status: discharged home eventually as planned. No further issues except the extra pokes and infection risk of new iv access.
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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 Key6392997
MDR Text Key245981347
Report Number3009211636-2017-05028
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 health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/22/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/09/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/28/2021
Device Model Number8888160341
Device Catalogue Number8888160341
Device Lot Number1620900196
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/03/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/14/2017
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial