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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 10/17/2017
Event Type  malfunction  
Manufacturer Narrative
An investigation was performed for the reported customer complaint: ¿the customer reported that there was leakage somewhere on the catheter body. ¿ a review of the device history record (dhr) for lot no. 1619500140 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. A sample was returned for evaluation. The sample consisted in one (1) 3. 5fr p. U. R. Umbil catheter. The visual inspection of the returned product noted no abnormalities. Functional testing was performed. The device was submerged into a water bath. The end was clamped and a syringe was used to inject air to observe leakage. No air bubbles were present. The reported customer complaint is not confirmed. A root cause could not be determined. This complaint will be utilized for tracking and trending purposes. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
An investigation of the reported condition was performed. A device history record (dhr) review revealed no discrepancies that may have contributed to a complaint of this reported condition. All quality assurance testing performed during manufacturing process was acceptable. The quality assurance review of the visual, physical and dimensional evaluation results indicated that the product met all 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 investigation. No probable root cause was determined since no sample, picture or video were received for investigation. Therefore, the reported condition is not confirmed. If the sample is returned in the future, this complaint will be re-opened for further investigation. The manufacturing site performed 100% leak testing as per procedure, which would identify this issue in the catheter assembly. A corrective or preventive action (capa) 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 non-conforming 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: 11/20/2017. An investigation is currently under way; upon completion the results will be forwarded. If information is provided in the future, a supplemental report will be issued.
 
Event Description
The customer reported that there was leakage somewhere on the catheter body.
 
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Brand NameARGYLE
Type of DeviceCATHETER, UMBILICAL ARTERY
Manufacturer (Section D)
COVIDIEN
edificio b20, calle #2
alajuela 0101
Manufacturer (Section G)
COVIDIEN
edificio b20, calle #2
alajuela 0101
Manufacturer Contact
edward almeida
15 hampshire street
mansfield, MA 02048
5084524151
MDR Report Key7045323
MDR Text Key247387121
Report Number3009211636-2017-05356
Device Sequence Number1
Product Code FOS
Combination Product (y/n)N
Reporter Country CodeBR
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 09/07/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/20/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8888160333
Device Catalogue Number8888160333
Device Lot Number1619500140
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/13/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/08/2018
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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