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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW RA CATH SET: 20 GA X 1-3/4"; WIRE GUIDE CATHETER
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ARROW INTERNATIONAL INC. ARROW RA CATH SET: 20 GA X 1-3/4"; WIRE GUIDE CATHETER Back to Search Results
Catalog Number RA-04020
Device Problem Obstruction of Flow (2423)
Patient Problem Insufficient Information (4580)
Event Date 11/24/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The complaint is reported as: "they are in the artery but no blood return w/ the set." no patient injury or complication reported.Additional information was requested, but not available at the time of this report.
 
Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
 
Event Description
The complaint is reported as: "they are in the artery but no blood return w/ the set." no patient injury or complication reported.Additional information was requested, but not available at the time of this report.
 
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Brand Name
ARROW RA CATH SET: 20 GA X 1-3/4"
Type of Device
WIRE GUIDE CATHETER
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key11027324
MDR Text Key222039808
Report Number9680794-2020-00532
Device Sequence Number1
Product Code DQX
Combination Product (y/n)N
PMA/PMN Number
K810675
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,user facility
Type of Report Initial,Followup
Report Date 11/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue NumberRA-04020
Device Lot Number14F2G0150
Was Device Available for Evaluation? Yes
Date Manufacturer Received01/12/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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