ANGIODYNAMICS H7496013022111

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-07-12 for ANGIODYNAMICS H7496013022111 manufactured by Angiodynamics.

Event Text Entries

[150882980] A review of the device history records was performed for the indicated packaging and component lots for any deviations related to the reported defect of the complaint. The review confirms that the lots met all material, assembly and performance specifications. The recent angiodynamics complaint report was reviewed for the syringe product family and the failure mode "air bubbles. " no adverse trend was identified. The end user hospital's reported complaint description cannot be confirmed nor can a root cause be established, as no sample was returned. The angiographic syringes are subjected to multiple inspections during production including visual inspections under magnification for molding defects, visual inspection of the male luer locks, and in-process leak testing. ((b)(4)).
Patient Sequence No: 1, Text Type: N, H10


[150882981] As reported by hospital, the seal (stopper) on the plunger of the 10ml angiographic syringe packaged within their convenience kit "is not tight and there is wiggle room causing air to get into the system at the back portion of the syringe. " this has been observed during prep. No air has been injected into a patient. No samples have been retained.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1317056-2019-00087
MDR Report Key8786346
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-07-12
Date of Report2019-07-12
Date of Event2019-06-17
Date Mfgr Received2019-06-17
Device Manufacturer Date2019-04-29
Date Added to Maude2019-07-12
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 NameCONVENIENCE KIT
Product CodeOEZ
Date Received2019-07-12
Catalog NumberH7496013022111
Lot Number5465008
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerANGIODYNAMICS
Manufacturer Address10 GLENS FALLS TECHNICAL PARK GLENS FALLS NY 12801 US 12801


Patients

Patient NumberTreatmentOutcomeDate
10 2019-07-12

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