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U.S. Department of Health and Human Services

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

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3.5FR URETHANE UMB CATH CATHETER, UMBILICAL ARTERY Back to Search Results
Model Number 8888160333
Device Problem Break (1069)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 08/01/2021
Event Type  malfunction  
Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.   as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.   if additional information or the sample is received, the investigation will be reopened and responded to accordingly.
 
Event Description
The customer stated that during the removal of the uvc, the uvc broke 1. 5cm above the insertion site. The catheter line was held in place until the provider arrived. The entire remaining length was removed with a hemostat. Blood loss was minimal.
 
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Brand Name3.5FR URETHANE UMB CATH
Type of DeviceCATHETER, UMBILICAL ARTERY
MDR Report Key12474739
MDR Text Key272670069
Report Number3009211636-2021-00765
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 other
Type of Report Initial
Report Date 09/15/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8888160333
Device Catalogue Number8888160333
Device Lot Number2007100042
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/14/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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