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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN ARGYLE CATHETER, UMBILICAL ARTERY

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COVIDIEN ARGYLE CATHETER, UMBILICAL ARTERY Back to Search Results
Model Number 8888160333
Device Problem Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/29/2017
Event Type  malfunction  
Manufacturer Narrative
Submit date: 2/26/2018. The incident sample has been requested but to date has not been received for evaluation. If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.
 
Event Description
The customer reports a leak was noticed in the catheter. According to nurse the catheter had a leak that was visible about 10cm from the proximal end as a long opening. The catheter was removed immediately as leak noticed and a pic line has been introduced to the premature infant.
 
Manufacturer Narrative
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. The actual sample involved in the reported incident was not returned for evaluation. No additional information, pictures or videos were received. Consequently, it was not possible to evaluate it as part of a comprehensive failure investigation. No probable cause was found since no sample, picture or video were received for testing, therefore the defect is not confirmed. If the sample is returned in the future, this complaint will be re-opened for further investigation. Leakage is a potential failure as per product specifications. However, manufacturing performs 100% leak testing as per procedure, which would identify this issue in the catheter assembly. 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
An investigation was performed for the reported customer complaint: ¿the customer reports a leak was noticed in the catheter. According to nurse the catheter had a leak that was visible about 10cm from the proximal end as a long opening. The catheter was removed immediately as leak noticed and a pic line has been introduced to the premature infant. ¿ a review of the device history records (dhrs) for the reported lot numbers indicates product and specification requirements were met with no non-conforming product identified relating to this customer report. A lot cannot be released unless it passes all quality and conformance requirements. In-process procedures are also in place to prevent nonconforming product in the manufacturing process. This ensures components and finished products meet all quality inspection standards. These controls include, but are not limited to: material verification/certification processes, dimensional specifications, statistical samplings, periodic audits, process inspections, machine maintenance/operation and personnel training and certification. A sample was returned for evaluation. The sample consisted in one (1) used uvc catheter, which came inside a generic plastic bag. The sample presented signs of use (remains of blood). The sample received did not reference the corresponding lot number. Under water test was performed and a leak below the strain relief could be identified in the catheter. Magnified pictures were taken and in the sample a tear/hole was observed. Through visual evaluation it was observed that the catheter returned had a tear/hole below the strain relief. 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 a period of time without issues, which implies that the event occurred after customer manipulation. Pressure testing is conducted for all catheters. The tear/hole found during sample evaluation would have been detected in this step. The reported issue occurred after being in use in a patient. Based on the available information, it can be concluded that product was manufactured according to specifications. The customer reported issue most likely occurred during use caused due to an inappropriate manipulation by the user. The reported customer complaint is confirmed. The probable root cause is customer misuse. This complaint will be used for trending purposes. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameARGYLE
Type of DeviceCATHETER, UMBILICAL ARTERY
Manufacturer (Section D)
COVIDIEN
edificio b20, calle #2
alajuela 20101
Manufacturer (Section G)
COVIDIEN
edificio b20, calle #2
alajuela 20101
Manufacturer Contact
edward almeida
15 hampshire street
mansfield, MA 02048
5084524151
MDR Report Key7297686
MDR Text Key101011626
Report Number3009211636-2018-00061
Device Sequence Number1
Product Code FOS
Combination Product (y/n)N
Reporter Country CodeIS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/15/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8888160333
Device Catalogue Number8888160333
Device Lot Number1633500149,1620900121
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/10/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/05/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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