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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN UNKNOWN NEONATAL UMBILICAL VESSEL CATHER

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COVIDIEN UNKNOWN NEONATAL UMBILICAL VESSEL CATHER Back to Search Results
Model Number UNKNOWN NEONATAL
Device Problem Malposition of Device (2616)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  Injury  
Manufacturer Narrative
Submit date: 2/29/2016. 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 states that the catheter is folding back on itself after being inserted into the patient. The customer states they are unable to get the correct placement. After placing the line, they felt it was placed correctly, but in checking the x-ray found that it had flipped back on itself. After removing the line, the uvc did not appear to be damaged in any way and had flipped back to straight. The customer stated that the uvc had to be pulled and replaced. There was no harm or medical intervention.
 
Manufacturer Narrative
The complaint sample was not returned to the manufacturing site for review. The lot number was not provided. All device history record (dhr) are reviewed for accuracy prior to product release. Because the sample was not returned, there is not enough evidence to determine what could cause this event. The following potential causes were identified either to this document operator error, instructions for use (ifu)¿s not followed: connections, infused substances, inspection not performed adequately, material composition. However, without the sample it is not possible to determine a specific root cause for this issue. Should the sample be returned in the future, this complaint will be re-opened for further investigation. There are no triggers or trends found for this event therefore no further actions are required for this investigation. It must be noted that in-process controls such as personnel training, incoming quality acceptance testing for raw material, in process visual inspection and visual acceptance sampling are in place to prevent nonconforming product from leaving the manufacturing operations, environmental and product biological monitoring. This complaint will be used for tracking and trending purposes.
 
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Brand NameUNKNOWN NEONATAL
Type of DeviceUMBILICAL VESSEL CATHER
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 20101
CS 20101
Manufacturer Contact
thom mcnamara
15 hampshire street
mansfield, MA 02048
5084524811
MDR Report Key5466525
MDR Text Key39238754
Report Number3009211636-2016-00102
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 02/05/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/29/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUNKNOWN NEONATAL
Device Catalogue NumberUNKNOWN NEONATAL
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/10/2016
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

Patient Treatment Data
Date Received: 02/29/2016 Patient Sequence Number: 1
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