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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN 3.5FR URETHANE UMB CATH UMBILICAL VESSEL CATHETER

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COVIDIEN 3.5FR URETHANE UMB CATH UMBILICAL VESSEL CATHETER Back to Search Results
Model Number 8888160333
Device Problems Crack (1135); Fluid Leak (1250)
Patient Problem Exsanguination (1841)
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 05/11/2016 that a customer had an issue with an umbilical vessel catheter (uvc). The customer reports the umbilical venous catheter had a crack in the hub, causing slight exsanguination and leaking of central line fluids from a nicu patient.
 
Manufacturer Narrative
Submit date: the lot number was not provided therefore a device history record (dhr) review could not be performed. A sample was received for analysis and investigation. It consisted in one uvc catheter which came inside a generic plastic bag and it presented signs of use. A visual inspection was performed and the sample presented signs of use and there was also an unknown device attached to the uvc catheter which contained blood residues. In order to confirm the reported defect, functional test was performed and as a result the leakage was not confirmed for both devices. Based on the available information, it can be concluded that product was manufactured according to specifications and the device functioned as intended for the reported amount of time; therefore the most probable root cause can be considered as customer perception, the clinician may have confused blood residues with leaking. Blood residues could be caused by the treatment or other condition in the patient. No complaint triggers or trends were identified, therefore further corrective or preventive actions were not required. 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 according to product specifications 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 Name3.5FR 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 solulfons sa
edificio 820 calle #2 zona franca coyol
alajuela
CS
Manufacturer Contact
edward almeida
15 hampshire street
mansfield, MA 02048
5084524151
MDR Report Key5705401
MDR Text Key46798428
Report Number3009211636-2016-00226
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 company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/11/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/08/2016
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? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/03/2016
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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