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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARTERIAL CATH. SET: 20 GA X 8CM CATHETER PERCUTANEOUS

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ARROW INTERNATIONAL INC. ARTERIAL CATH. SET: 20 GA X 8CM CATHETER PERCUTANEOUS Back to Search Results
Model Number IPN037640
Device Problem Unable to Obtain Readings (1516)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/18/2019
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that "after the arterial catheter has been in place for 24 to 48 hours, no arterial pressure measurement is possible. Measurement curve very flat to no longer available. Device was placed into the radial artery; as a result, a new device was placed. ".

 
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Brand NameARTERIAL CATH. SET: 20 GA X 8CM
Type of DeviceCATHETER PERCUTANEOUS
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL CR, A.S.
jamska 2359/47
zdar nad sazavou 591 0 1
EZ 591 01
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
9194334854
MDR Report Key9547280
MDR Text Key173909678
Report Number3006425876-2020-00046
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeGM
PMA/PMN NumberK093050
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 12/18/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/03/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberIPN037640
Device Catalogue NumberSAC-00820-PBX
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/08/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/31/2020
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 01/03/2020 Patient Sequence Number: 1
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