ARROW THORACENTESIS KIT AK-01000-J

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-01-03 for ARROW THORACENTESIS KIT AK-01000-J manufactured by Arrow International Inc..

Event Text Entries

[177605149] (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[177605150] The customer reports: the kit was opened by a doctor who found the tubing to be cracked on inspection before she commenced a chest drain insertion. The incident report notes that the blue attachment between the luer lock and the tube was cracked. The device was likely to have been cracked in manufacture.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9680794-2020-00017
MDR Report Key9546696
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-01-03
Date of Report2019-12-16
Date of Event2019-12-12
Date Mfgr Received2020-01-13
Device Manufacturer Date2019-02-26
Date Added to Maude2020-01-03
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactKATHARINE TARPLEY
Manufacturer Street3015 CARRINGTON MILL BLVD
Manufacturer CityMORRISVILLE NC 27560
Manufacturer CountryUS
Manufacturer Postal27560
Manufacturer Phone9194334854
Manufacturer G1ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.
Manufacturer StreetAVE. WASHINGTON 3701 COLONIA PANAMERICANA, CHIHUAHUA
Manufacturer CityCHIHUAHUA 31200
Manufacturer CountryMX
Manufacturer Postal Code31200
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameARROW THORACENTESIS KIT
Generic NameCATHETER AND TIP SUCTION
Product CodeJOL
Date Received2020-01-03
Catalog NumberAK-01000-J
Lot Number13F19B0624
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerARROW INTERNATIONAL INC.
Manufacturer AddressREADING PA


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-03

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