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Model Number 8888160333
Device Problem Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/04/2017
Event Type  malfunction  
Manufacturer Narrative
This complaint was investigated. 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 used sample was received for testing and investigation. The sample presented blood inside the tubing. Visual inspection of the catheter revealed that the tubing was split approximately twenty-one cm below of the strain relief. Its analysis revealed an irregular cut in the tubing. Additionally, water test was performed and additional leaks were not found. The possible root causes were identified: material a) defective material: multiple components are used in the manufacture of this product. Components properties are tested by the suppliers and there are controls in place in the manufacturing site to prevent non-conforming material to be used. All dhr are reviewed for accuracy prior to product release. In addition, during manufacturing process, catheters are submitted to a 100% pressure testing. The defect occurred after being in use in a patient for an undetermined amount of time, therefore this cause is discarded. Man a) customer misuse (excessive force, inappropriate use of cleaning agents, sharp objects, etc. ): through visual evaluation it was observed that the catheter was separate in two sections. Due to the appearance of the catheter received, it is possible that the catheter was damaged by instruments with sharp or rough edges during clinical use, resulting in a catheter leakage. Additionally, the catheter was in use for an undetermined amount of time without issues, which implies that the defect occurred after customer manipulation. 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]. There are several 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 defect found caused a leak which would be identified during assembly operations, since manufacturing performs 100% pressure testing during production. Per the event description, the catheter was cleaned with alcohol. Based on the available information this potential cause could not be discarded. Operator failed to follow process or inspection procedures: 100% of the catheters are submitted to a pressure test. The cut that was found during sample evaluation would be detected in this step. Additionally, the defect was noticed during use, further after priming the catheter. For these reasons this potential cause is discarded. Machine: no potential causes were identified under equipment category. Method: no potential causes were identified under method category. Measurement: no potential causes were identified under this category. This defect has been confirmed. The product sample was returned to the manufacturing site for review. Based on the available information, it can be concluded that product was manufactured according to specifications and the device functioned as intended for an undetermined amount 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. No trends or triggers have been found, therefore, a corrective or 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. 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: 4/3/17. An investigation is currently under way; upon completion the results will be forwarded.
Event Description
The customer reports a leak was observed just below the hub/butterfly where the catheter is joined. The arterial line broke resulting in blood loss and requiring a replacement.
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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 Key6453141
MDR Text Key251344563
Report Number3009211636-2017-05064
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 12/01/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/03/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/21/2021
Device Model Number8888160333
Device Catalogue Number8888160333
Device Lot Number1611200133
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/24/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/06/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/21/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown