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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IAG BC PRO GLOBAL GRN 18GA X 1.16IN INTRAVASCULAR CATHETER

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IAG BC PRO GLOBAL GRN 18GA X 1.16IN INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 381044
Device Problem Free or Unrestricted Flow (2945)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/12/2021
Event Type  malfunction  
Manufacturer Narrative
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 iag bc pro global grn 18ga x 1. 16in had air bubbles, which resulted in hemolyzed samples. The following information was provided by the initial reporter: air bubbles appeared when the catheter was used for small blood flows, resulting in hemolyzed samples.
 
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Brand NameIAG BC PRO GLOBAL GRN 18GA X 1.16IN
Type of DeviceINTRAVASCULAR CATHETER
MDR Report Key12298210
MDR Text Key265801985
Report Number1710034-2021-00685
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K201075
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 09/10/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number381044
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/10/2021
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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