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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIAN 3.5FR URETHANE UMB CATH CATHETER, UMBILICAL ARTERY

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COVIDIAN 3.5FR URETHANE UMB CATH CATHETER, UMBILICAL ARTERY Back to Search Results
Model Number 8888160333
Device Problem Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation. If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.
 
Event Description
The customer states the uvc line was pulled back from 6. 75 to 4 cm due to concern on the x-ray that the line was in an unfavorable position. When pulling the line back, there was a backup of blood in the catheter that was leaking onto the baby's diaper. Upon examination, it was noted that the catheter had been severed in half due to an unknown cause. The remainder of the line was able to be retrieved. Lab work was ordered to rule out infection. A new line was placed to administer iv nutrition. Iv antibiotics were ordered prophylactically.
 
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Brand Name3.5FR URETHANE UMB CATH
Type of DeviceCATHETER, UMBILICAL ARTERY
Manufacturer (Section D)
COVIDIAN
edificio b20 calle #2 zona fra
alajuela
CS
Manufacturer (Section G)
COVIDIEN
edificio b20 calle #2 zona fra
alajuela
CS
Manufacturer Contact
edward almeida
15 hampshire street
mansfield, MA 02048
5084524151
MDR Report Key7846949
MDR Text Key119344764
Report Number3009211636-2018-00605
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 09/05/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/05/2018
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8888160333
Device Catalogue Number8888160333
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/06/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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