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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN UNKNOWN NEONATAL UVC

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COVIDIEN UNKNOWN NEONATAL UVC Back to Search Results
Model Number UNKNOWN NE
Device Problems Material Fragmentation (1261); Occlusion Within Device (1423)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Injury  
Manufacturer Narrative
Submit date: 1/27/2017. An investigation is currently under way. Upon completion the results will be forwarded.
 
Event Description
It was reported to covidien on (b)(6) 2017 that a customer had an issue with an enteral feeding pump. The customer reports that the dressing was being removed to prepare for new uvc placement due to the old line being occluded and not drawing back despite correct location per x-ray. The nurse noticed two separate catheters, the 5f catheter had been broken and separated into two pieces with one part remaining in patient. The line was clamped and removed with the catheter still intact.
 
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Brand NameUNKNOWN NEONATAL
Type of DeviceUVC
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 st
mansfield, MA 02048
5084524151
MDR Report Key6283135
MDR Text Key65956958
Report Number3009211636-2017-00060
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 other
Reporter Occupation
Type of Report Initial
Report Date 01/04/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/27/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNKNOWN NE
Device Catalogue NumberUNKNOWN NE
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/04/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 01/27/2017 Patient Sequence Number: 1
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