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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI CVC KIT: 4-L 8.5 FR X 20 CM AGB+ CATHETER,INTRAVASCULAR,THERAPE

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ARROW INTERNATIONAL LLC ARROW PI CVC KIT: 4-L 8.5 FR X 20 CM AGB+ CATHETER,INTRAVASCULAR,THERAPE Back to Search Results
Model Number IPN922683
Device Problem Material Separation (1562)
Patient Problem Insufficient Information (4580)
Event Date 04/20/2022
Event Type  malfunction  
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Brand NameARROW PI CVC KIT: 4-L 8.5 FR X 20 CM AGB+
Type of DeviceCATHETER,INTRAVASCULAR,THERAPE
Manufacturer (Section D)
ARROW INTERNATIONAL LLC
morrisville NC
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 Key14979074
Report Number9680794-2022-00413
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier10801902202557
UDI-Public10801902202557
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K071538
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/20/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/11/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberIPN922683
Device Catalogue NumberASK-45854-BJC1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received08/09/2022
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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