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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN 3.5FR URETHANE UMB CATH UVC

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COVIDIEN 3.5FR URETHANE UMB CATH UVC Back to Search Results
Model Number 8888160333
Device Problems Backflow (1064); Fluid Leak (1250); Improper Flow or Infusion (2954)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/18/2016
Event Type  malfunction  
Manufacturer Narrative
Submit date: 10/3/2016. 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 rn noted blood backing up into the catheter and also that the catheter and area under the catheter was damp. Nnp was called to the bedside and catheter was assessed and an area just proximal to the hub that tpn/il was leaking from. Picc catheter was placed as alternate form of access. Unclear how long the catheter integrity was compromised. There was no medical intervention required.
 
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Brand Name3.5FR URETHANE UMB CATH
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 street
mansfield, MA 02048
5084524151
MDR Report Key5995343
MDR Text Key56557991
Report Number3009211636-2016-00418
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 09/19/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/03/2016
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?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/19/2016
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

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