MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYNAMICS; CONVENIENCE KIT

Catalog Number	H7496013022111
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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)).
Event or Problem Description
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.

• Brand Name: ANGIODYNAMICS
• Common Device Name: CONVENIENCE KIT
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 8786346
• Report Number: 1317056-2019-00087
• Device Sequence Number: 2038200
• Product Code: OEZ
• UDI-Device Identifier: H7496013022111
• UDI-Public: H7496013022111
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: H7496013022111
• Device Lot Number: 5465008
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2019
• Initial Report FDA Received Date: 07/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1