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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: 5FR TRPL-LUMN UMB VSL CATH CATHETER, UMBILICAL ARTERY

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5FR TRPL-LUMN UMB VSL CATH CATHETER, UMBILICAL ARTERY Back to Search Results
Model Number 8888160648
Device Problem Fluid Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
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. If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
 
Event Description
The customer reported that the patient had a 5fr triple lumen uvc. The facility was unable to draw blood off the uvc and air bubbles were noted when attempting to draw off the line. All three ports/lumens flushed well. When tpn/medication was reattached to the uvc, leaking fluid was noted where the line bifurcates to the three lumens. The uvc was removed once a picc line was inserted to replace it.
 
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Brand Name5FR TRPL-LUMN UMB VSL CATH
Type of DeviceCATHETER, UMBILICAL ARTERY
MDR Report Key12635289
MDR Text Key276584549
Report Number3009211636-2021-00767
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
Report Date 10/14/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8888160648
Device Catalogue Number8888160648
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/23/2021
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

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