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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN 5.0FR URETHANE UMB CATH; CATHETER, UMBILICAL ARTERY
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COVIDIEN 5.0FR URETHANE UMB CATH; CATHETER, UMBILICAL ARTERY Back to Search Results
Model Number 8888160341
Medical Device Problem Code Obstruction of Flow (2423)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 11/16/2020
Type of Reportable Event Malfunction
Additional 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.  as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
 
Event or Problem Description
The customer reported that they are not able to draw blood using the 5.0 fr umbilical venous catheter (uvc).There was no patient harm involved.
 
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Brand Name
5.0FR URETHANE UMB CATH
Common Device Name
CATHETER, UMBILICAL ARTERY
Manufacturer (Section D)
COVIDIEN
edificio b20 calle #2 zona fra
alajuela
CS 
MDR Report Key10877625
Report Number3009211636-2020-00724
Device Sequence Number4001977
Product Code FOS
UDI-Device Identifier20884527005120
UDI-Public20884527005120
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,user f
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 11/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device No Information
Device Model Number8888160341
Device Catalogue Number8888160341
Device Lot Number2020500107
Was Device Available for Evaluation? Yes
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 11/16/2020
Initial Report FDA Received Date11/20/2020
Patient Sequence Number1
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