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Model Number 8888160333
Device Problem Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/01/2017
Event Type  malfunction  
Manufacturer Narrative
An investigation of the reported condition was performed. A review of device history record (dhr) revealed no discrepancies that may have contributed to the reported condition. The 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, dhr was reviewed for accuracy prior to product release. The customer returned a s ample for evaluation. The sample consisted of one single uvc catheter, used inside a generic plastic bag. Under water test was performed and a leak below the strain relief could be identified in the catheter. Magnified pictures were taken, and a hole was observed in the sample. The reported condition was confirmed. An ishikawa diagram was used to determine the potential causes for this event, based on: 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. This cause is discarded. Man, customer misuse (excessive force, inappropriate use of cleaning agents, sharp objects, instruments, wrong technique, etc. ): through sample evaluation, it was observed that the catheter that was returned 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 warning [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 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 found during sample evaluation would be detected in this step. Additionally, the reported condition was noticed during use. For these reasons, this potential cause is discarded. Machine: no potential causes were identified under equipment category. So, this issue was found after the manufacturing process. According to visual inspection was performed at 100% of molded parts, but document visual inspection every 30 minutes, method: no potential causes were identified under method category. Additionally, 100% of the catheters are submitted to a pressure test for any issue related with the event description. 5) measurement: no potential causes were identified under this category. In addition, the parameters of the leak test are checked against the procedure table, so that the tests are performed, and the parameters are within specifications. 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. Therefore, the most probable root cause can be considered as unintentional misuse; this incident was most likely due to damage during use caused due to an inappropriate manipulation by the user. No complaint triggers or trends were identified, and no harm was reported by this complaint, and therefore no corrective or preventive actions are required. 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 on leaving the manufacturing operations. This complaint will be used for tracking and trending purpose. If information is provided in the future, a supplemental report will be issued.
Manufacturer Narrative
Submit date: 8/2/17. An investigation is currently under way; upon completion the results will be forwarded.
Event Description
The customer reports that the catheter was leaking fluid at the hub of the line. A new picc was inserted uvc removed.
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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 Key6759991
MDR Text Key262149454
Report Number3009211636-2017-05247
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 01/23/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/02/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/28/2021
Device Model Number8888160333
Device Catalogue Number8888160333
Device Lot Number1620900195
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 Received07/04/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/28/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown