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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN 5.0FR URETHANE UMB CATH UMBILICAL VESSEL CATHETER

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COVIDIEN 5.0FR URETHANE UMB CATH UMBILICAL VESSEL CATHETER Back to Search Results
Model Number 8888160341
Device Problems Crack (1135); Fluid Leak (1250); Connection Problem (2900)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
An investigation is currently underway. Upon completion, the results will be forwarded.
 
Event Description
It was reported to covidien on (b)(6) 2016 that a customer had an issue with an umbilical vessel catheter (uvc). The customer reports that the uvc was leaking just below the hub connection where the catheter is joined. Customer reports a crack in the line.
 
Manufacturer Narrative
The actual sample involved in the reported incident was not returned for evaluation. No additional information, pictures or videos were received. Since no sample was returned for examination, it was not possible to evaluate it as part of a comprehensive failure investigation. A device history record (dhr) review 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 dhrs are reviewed for accuracy prior to product release. If the sample is returned in the future, this complaint will be re-opened for further investigation. It is not possible to confirm a root cause for this event. 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.
 
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Brand Name5.0FR URETHANE UMB CATH
Type of DeviceUMBILICAL VESSEL CATHETER
Manufacturer (Section D)
COVIDIEN
covidien manufacturing solutions sa
edificio 820 calle #2 zona france coyol
alajuela
CS
Manufacturer (Section G)
COVIDIEN
covidien manufacturing solutions sa
edificio 820 calle #2 zona france coyol
alajuela
CS
Manufacturer Contact
edward almeida
15 hampshire street
mansfield, MA 02048
5084524151
MDR Report Key5763199
MDR Text Key49281548
Report Number3009211636-2016-00288
Device Sequence Number1
Product Code FOS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/21/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/30/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8888160341
Device Catalogue Number8888160341
Device Lot Number1535700107
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/03/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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