ANGIODYNAMICS H965601910111

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-05-20 for ANGIODYNAMICS H965601910111 manufactured by Angiodynamics.

Event Text Entries

[145487194] It has been indicated that used and unused device samples will be returned for evaluation, however they have not yet arrived. A supplemental medwatch will be submitted upon completion of the investigation. ((b)(4)).
Patient Sequence No: 1, Text Type: N, H10


[145487195] As reported, with a convenience kit, air bubbles were believed to be entering the line at the connection of the disposable transducer and the pressure monitoring line. "the connections were then tightened, and eventually changed out. " no air was injected and there was no patient injury. Samples are being returned to angiodynamics for evaluation.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1317056-2019-00067
MDR Report Key8623260
Report SourceUSER FACILITY
Date Received2019-05-20
Date of Report2019-08-13
Date Mfgr Received2019-04-26
Device Manufacturer Date2019-03-20
Date Added to Maude2019-05-20
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. LAW RYAN
Manufacturer Street10 GLENS FALLS TECHNICAL PARK
Manufacturer CityGLENS FALLS NY 12801
Manufacturer CountryUS
Manufacturer Postal12801
Manufacturer G1ANGIODYNAMICS
Manufacturer Street10 GLENS FALLS TECHNICAL PARK
Manufacturer CityGLENS FALLS NY 12801
Manufacturer CountryUS
Manufacturer Postal Code12801
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameANGIODYNAMICS
Generic NameCARDIOVASCULAR PROCEUDRE KIT
Product CodeOEZ
Date Received2019-05-20
Returned To Mfg2019-07-09
Catalog NumberH965601910111
Lot Number5450161
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerANGIODYNAMICS
Manufacturer Address10 GLENS FALLS TECHNICAL PARK GLENS FALLS NY 12801 US 12801


Patients

Patient NumberTreatmentOutcomeDate
10 2019-05-20

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