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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANGIOCATH PLUS 24GA X 0.75IN INTRAVASCULAR CATHETER

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ANGIOCATH PLUS 24GA X 0.75IN INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 382412
Device Problem Material Perforation (2205)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/16/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Initial reporter fax#: (b)(6). A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that angiocath plus 24ga x 0. 75in needle went through the catheter. The following information was provided by the initial reporter: when insertion catheter, it was difficult to advance and was torn.
 
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Brand NameANGIOCATH PLUS 24GA X 0.75IN
Type of DeviceINTRAVASCULAR CATHETER
MDR Report Key12178428
MDR Text Key263581176
Report Number8041187-2021-00595
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 08/10/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number382412
Device Lot Number0051058
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/18/2021
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/10/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/20/2020
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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