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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN UNKNOWN NEONATAL UMBILICAL VESSEL CATHETER

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COVIDIEN UNKNOWN NEONATAL UMBILICAL VESSEL CATHETER Back to Search Results
Model Number UNKNOWN NEONATAL
Device Problem Material Fragmentation (1261)
Patient Problem Foreign Body Reaction (1868)
Event Type  Injury  
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 a 3. 5 dual lumen umbilical vessel catheter (uvc) was placed emergently in the main or following delivery of a 0. 415 gram infant via emergency caesarian section. The flushed 3. 5 fr double lumen catheter was advanced to 7 cm without difficulty. The line flushed and drew back easily, a 3. 0 silk suture was not available in the or room at the time; however, a 3. 0 coated suture was available. The catheter was sutured in place at 7cm with the 3. 0 coated suture. After transferring the infant to the nicu an x-ray was taken of the line placement and showed the uvc needed to be adjusted back 1. 5 cm. While the bedside nurse was pulling the uvc back to the correct position, the catheter snapped at the 6cm mark. The nurse was unable to grab the proximal tip and the catheter sunk deeper into the umbilical stump, 6cm of catheter remained in the umbilical vein and was not able to be retrieved. The patient was transferred to a specialty hospital for surgical removal of the catheter.
 
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Brand NameUNKNOWN NEONATAL
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 Key5975428
MDR Text Key55567257
Report Number3009211636-2016-00410
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,user f
Reporter Occupation
Type of Report Initial
Report Date 09/12/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/23/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNKNOWN NEONATAL
Device Catalogue NumberUNKNOWN NEONATAL
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/12/2016
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 Unkown

Patient Treatment Data
Date Received: 09/23/2016 Patient Sequence Number: 1
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