MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYNAMICS; ANGIOGRAPHIC CONTROL SYRINGE

Catalog Number	H965700950071
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The syringe from the reported event has been returned to angiodynamics, however the device evaluation is still in process.Upon completion of the investigation, a supplemental medwatch will be submitted.((b)(4)).
Event or Problem Description
As reported by angiodynamics' distributor in (b)(4), when utilizing an angiographic convenience kit, " after the lines were connected with contrast and saline, the control syringe was connected to the manifold.Then, as air removal was attempted, a foreign substance ws found inside the syringe." there were no patient complications nor injury.The used syringe has been returned to angiodynamics for evaluation.
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 (b)(6) 2019 fluid management complaint report was reviewed for the syringe product family and the failure mode " foreign matter within fluid path." no adverse trend was identified.In addition, this is the only reported complaint for this failure mode in the past 15 months for the syringe product family.A visual inspection was performed on the on the returned syringe and it was confirmed to be defective for a foreign matter (fm) substance.The syringe was sectioned to remove the foreign matter for further inspection.The fm was viewed under magnification and looked to be a rubbery substance of undeterminable origin (either the nature of the foreign matter, or the source).No other issues were observed with the syringe.This is the only reported complaint for this failure mode of foreign matter inside a syringe in the past 15 months (for the syringe product family).As such, this is deemed to be an isolated incident.(b)(4).

• Brand Name: ANGIODYNAMICS
• Common Device Name: ANGIOGRAPHIC CONTROL SYRINGE
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 8802722
• Report Number: 1317056-2019-00094
• Device Sequence Number: 16223392
• Product Code: DXT
• UDI-Device Identifier: H965700950071
• UDI-Public: H965700950071
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K873955
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2019

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: 11/30/2021
• Device Catalogue Number: H965700950071
• Device Lot Number: 5405842
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2019
• Supplement Date Received by Manufacturer: 06/21/2019
• Initial Report FDA Received Date: 07/18/2019
• Supplement Report FDA Received Date: 08/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1