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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW EXT DWELL CATH BASIC 20GAX6CM CATHETER INTRAVASCULAR THERAPE

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ARROW INTERNATIONAL INC. ARROW EXT DWELL CATH BASIC 20GAX6CM CATHETER INTRAVASCULAR THERAPE Back to Search Results
Model Number IPN037864
Device Problem Obstruction of Flow (2423)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/30/2021
Event Type  malfunction  
Event Description
Endurance catheter placed in patient on (b)(6) 2021. It worked well and medications were given for 24 hours. On (b)(6) 2021, they could not flush the line. The line was removed from the patient. No patient harm. The patient's condition is reported as fine.
 
Manufacturer Narrative
(b)(4).
 
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Brand NameARROW EXT DWELL CATH BASIC 20GAX6CM
Type of DeviceCATHETER INTRAVASCULAR THERAPE
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.
ave. washington 3701
colonia panamericana, chihuahua
chihuahua 31200
MX 31200
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
MDR Report Key13315198
MDR Text Key284819919
Report Number9680794-2022-00009
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier10801902133004
UDI-Public10801902133004
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K163513
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/21/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberIPN037864
Device Catalogue NumberEDC-00620-B
Device Lot Number13F21J0282
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/06/2022
Is the Reporter a Health Professional? No
Date Manufacturer Received02/18/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/08/2021
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: 01/21/2022 Patient Sequence Number: 1
Treatment
NOT REPORTED
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