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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: 5.0FR URETHANE UMB CATH CATHETER, UMBILICAL ARTERY

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5.0FR URETHANE UMB CATH CATHETER, UMBILICAL ARTERY Back to Search Results
Model Number 8888160341
Device Problem Fluid Leak (1250)
Patient Problem Insufficient Information (4580)
Event Date 05/08/2021
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.   as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
 
Event Description
Customer reports: the single lumen umbilical arterial catheter was leaking blood. It was noted that there was a hole in the catheter tubing within the first 2 inches from connection end.
 
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Brand Name5.0FR URETHANE UMB CATH
Type of DeviceCATHETER, UMBILICAL ARTERY
MDR Report Key11802627
MDR Text Key252361480
Report Number3009211636-2021-00746
Device Sequence Number1
Product Code FOS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 09/01/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8888160341
Device Catalogue Number8888160341
Device Lot Number1923400325
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/08/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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