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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN UVC TRAY/5.0 FR PU

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COVIDIEN UVC TRAY/5.0 FR PU Back to Search Results
Model Number 8888160432
Device Problems Fluid Leak (1250); Connection Problem (2900)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/09/2016
Event Type  malfunction  
Manufacturer Narrative
Submit date: 10/07/2016. An investigation is currently under way; 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 a uvc. The customer reports the catheter was used on a (b)(6) infant. The uvc catheter was leaking blood near the hub, just above the hub where the extension tubing meets the hub and just below the hub where the catheter is joined. It was inserted on (b)(6) 2016 and the leaking was noticed on (b)(6) 2016. There was no harm to the patient. Medical intervention required was replacement of the uvc. Betadine antiseptic solution and 0. 9% saline solution was used to clean the area prior to insertion. The area was dry prior to the insertion. There was no difficulty handling the catheter during insertion and no difficulty securing the catheter. There was no tape used on the hub area of the catheter. The catheter was automatically secured from the hub site. The uvc was inserted into the umbilical cord. It was a single lumen continuous feed. After the procedure, normal 0. 9% saline solution was used to clean the patient's skin. The hub was not cleaned. The device was not replaced. There was a blood transfusion performed after the patient loss approximately 5ml of blood. The patient later went home after recovery.
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Brand NameUVC TRAY/5.0 FR PU
Type of DeviceUVC
Manufacturer (Section D)
covidien manufacturing solutions sa
edificio 820 calle #2 zona france coyol
Manufacturer (Section G)
covidien manufacturing solutions sa
edificio 820 calle #2 zona france coyol
Manufacturer Contact
edward almeida
15 hampshire street
mansfield, MA 02048
MDR Report Key6011470
MDR Text Key57317035
Report Number3009211636-2016-00420
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 10/04/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/07/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8888160432
Device Catalogue Number8888160432
Device Lot Number1527300078
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/04/2016
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