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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANGIOCATH BL 22GA X 1.0IN INTRAVASCULAR CATHETER

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ANGIOCATH BL 22GA X 1.0IN INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 381123
Device Problem Free or Unrestricted Flow (2945)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/15/2021
Event Type  malfunction  
Manufacturer Narrative
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 bl 22ga x 1. 0in had air in the line. The following information was provided by the initial reporter: this is a report about air in line with the use of angiocath. According to the customer's report, when connecting to the a line, air entered. The customer is suspecting that there may be a crack on the catheter or the catheter hub.
 
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Brand NameANGIOCATH BL 22GA X 1.0IN
Type of DeviceINTRAVASCULAR CATHETER
MDR Report Key12640273
MDR Text Key276664995
Report Number9610048-2021-00140
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K151698
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial
Report Date 09/28/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number381123
Device Lot Number9329998
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/17/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/13/2019
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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