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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 Known Impact Or Consequence To Patient (2692)
Event Date 05/17/2017
Event Type  malfunction  
Manufacturer Narrative
An investigation was performed for the reported customer complaint: ¿the umbilical artery catheter (uac) was noted to be spontaneously leaking at the distal portion of the thinnest part of the catheter, prior to the hub. The leakage was noted after a fluid change. The line was not pinched or clamped at all prior to leaking. It was later found that the prior rn had bent the line back upon itself, which led to a micro crack. ¿ no lot number was provided. A review of the device history report (dhr) was unable to be performed. However, 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. No product/sample was provided for evaluation. No additional information, pictures or videos were received. Therefore, a comprehensive investigation was unable to be conducted. The reported customer complaint could not be confirmed. A root cause could not be determined. 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: 7/27/17. An investigation is currently under way; upon completion the results will be forwarded. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
The customer states the umbilical artery catheter (uac) was noted to be spontaneously leaking at the distal portion of the thinnest part of the catheter, prior to the hub. The leakage was noted after a fluid change. The line was not pinched or clamped at all prior to leaking. It was later found that the prior rn had bent the line back upon itself, which led to a micro crack.
 
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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 Key6746930
MDR Text Key247387628
Report Number3009211636-2017-05240
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 08/15/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/27/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8888160333
Device Catalogue Number8888160333
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 Received06/29/2017
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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