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Model Number 8888160341
Device Problem Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/26/2017
Event Type  malfunction  
Manufacturer Narrative
The product related to this complaint is product code: 8888160341, product description: 35. 0fr p u r umbil cath x10, lot number 1713000079. A device history record (dhr) review revealed no discrepancies that may have contributed to a complaint. 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 used sample was received for analysis and investigation. The sample consisted in one used uvc catheter, which came inside a generic plastic bag. The sample demonstrates signs of use; blood residues. Underwater testing was performed there was no leakage as described in the complaint. Magnified pictures were taken and a clean cut below the butterfly was observed. Magnified pictures were taken and in the sample a tear/hole was observed. Based on the sample provided, the possible causes for the condition are: machine malfunction, unintentional customer misuse, product inspection inadequacy or not performed, or a sharp object was used that came into contact with the catheter are all possibilities. Sharp objects should not be used with a catheter. 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. There are a number of alternatives on the field like exposure to chemical agents, proximity to heat sources or manipulation per se, that may lead to tubing tear. Moreover, the condition found in this sample caused a leak which would be identified during assembly operations, since manufacturing performs 100% pressure testing during production. 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 unintentional misuse; this defect was most 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 performed in the plant 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: 11/14/2017. An investigation is currently underway. Upon completion, the results will be forwarded. If information is provided in the future, a supplemental report will be issued.
Event Description
The customer reports that a single lumen umbilical vessel catheter (uvc) was inserted, and immediately following insertion, it was noticed that the catheter was cracked/leaking just below the hub where the catheter is joined. The uvc was removed and a new uvc was inserted. The customer further reports that the skin was prepped with chlorhexidine/alcohol solution but did not come into contact with the uvc. The catheter tubing was not cleaned. There was no injury to the patient as a result.
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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 Key7031753
MDR Text Key255810706
Report Number3009211636-2017-05352
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 02/21/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/14/2017
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 Received10/26/2017
Was Device Evaluated by Manufacturer? Yes
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