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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INSYTE AUTOG BC BLU 22GA X 1.0IN INTRAVASCULAR CATHETER

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INSYTE AUTOG BC BLU 22GA X 1.0IN INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 382523
Device Problem Free or Unrestricted Flow (2945)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/14/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used. Medical device expiration date: unknown. A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed. Device manufacture date: unknown.
 
Event Description
It was reported that insyte autog bc blu 22ga x 1. 0in had air bubbles. The following information was provided by the initial reporter: it was reported that there are air bubbles entering the iv line.
 
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Brand NameINSYTE AUTOG BC BLU 22GA X 1.0IN
Type of DeviceINTRAVASCULAR CATHETER
MDR Report Key12163555
MDR Text Key261491942
Report Number1710034-2021-00572
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K110443
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 08/24/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number382523
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/24/2021
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? No
Type of Device Usage Initial

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