• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ARROW INTERNATIONAL INC. ARROW ARTERIAL CATH SET: 20GA X 8CM CATHETER, PERCUTANEOUS Back to Search Results
Model Number IPN030318
Device Problem Material Separation (1562)
Patient Problem Inflammation (1932)
Event Date 11/16/2020
Event Type  Malfunction  
Manufacturer Narrative

(b)(4).

 
Event Description

The complaint is reported as: the physician tried to pass the guidewire through the introducer needle and it "got stuck". At the third attempt to introduce the catheter in the patient's arm the guidewire "breaks and fractures". The physician withdrew the guidewire and introducer needle. It was reported the patient had "multiple punction at the skin and local inflammation". No medical intervention was required. Another device was placed without problem. The patient's condition was reported as "critical" unrelated to the device issue.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameARROW ARTERIAL CATH SET: 20GA 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
MDR Report Key11258710
MDR Text Key229865419
Report Number3006425876-2021-00101
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeCI
PMA/PMN NumberK093050
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/13/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/01/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberIPN030318
Device Catalogue NumberSAC-00820
Device LOT Number71F20D0641
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/01/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/09/2020
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-