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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 8888160341
Device Problem Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/10/2018
Event Type  malfunction  
Manufacturer Narrative
Submit date: 3/2/2018. 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. As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product. If information is provided in the future, a supplemental report will be issued.
 
Event Description
The customer reports the catheter leaking from the area near the connection hub/proximal end.
 
Manufacturer Narrative
A device history record (dhr) review revealed no discrepancies that may have contributed to a complaint of this reported condition. During the manufacturing process, all quality assurance testing was completed with acceptable results. 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. Manufacturing performs 100% leak testing as per procedure which would identify this issue as a part of the catheter assembly process. 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. The 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 the catheter leaking from the area near the connection hub/proximal end. ¿ a review of the device history record (dhr) for lot no. 1626500197 indicated the product was released meeting all quality standards. All dhrs are reviewed for accuracy prior to product release. 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. Multiple components are used in the manufacture of this product. 100% of the catheters produced are submitted to a pressure test which would identify this issue in the catheter. Sample was received for evaluation. One (1) used uvc catheter with two (2) syringes and a set of tubes, were returned inside a generic plastic bag and present signs of use (possibly remains of blood). Visual inspection was performed. The catheter was observed with a tear/hole below the strain relief that could have generated the leak. Potential causes of the reported condition include defective material, operator failed to follow process or inspection procedures, user did not follow instructions, machine malfunction, or measurement specifications. Information is insufficient to determine whether these scenarios occurred. 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 defect occurred after customer manipulation. The reported condition was confirmed. 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 complaint will be used for tracking and 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 Key7310289
MDR Text Key101402578
Report Number3009211636-2018-00068
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 08/21/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/02/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/22/2021
Device Model Number8888160341
Device Catalogue Number8888160341
Device Lot Number1626500197
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/22/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/24/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/22/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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