MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYNAMICS; CONTRAST CONTROLLER SPIKE ASSEMBLY

Catalog Number H965904000391

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem Not Applicable (3189)

Event Date 06/21/2017

Event Type  malfunction  

Manufacturer Narrative

It has been indicated that the device from the event report will be returned to angiodynamics for evaluation, but it has not yet arrived.Upon receipt of the sample and completion of the investigation, a supplemental medwatch will be submitted.(b)(4).

Event Description

As reported by angiodynamics' distributor in (b)(4), during an incoming product inspection at the distributor's warehouse, loose foreign matter was noted within the fluid path of a fluid delivery set.The device was not used, was not provided to a hospital, and is being returned to angiodynamics for evaluation.

Manufacturer Narrative

A review of the device history records was performed for the reported packaging lot item number h965904000391 for any deviations related to the reported defect of the complaint.The review confirms that the lot met all material, assembly and performance specifications.The august 2017 angiodynamics complaint report was reviewed for the contrast controller product family and the failure mode "lumen foreign material {loose}." no adverse trend was identified.Returned for evaluation was one unused contrast controller spike assembly.Based on the photos and sample supplied from the complaint reporter, the complaint of "loose foreign matter in fluid path" is deemed confirmed.The size of the loose foreign matter (fm) was estimated to be less than.25mm2 using tappi dirt estimation chart.However, per the specifications noted in angiodynamics manufacturing procedure for visual inspection (loose fm not greater than.25mm2), the loose fm is of an acceptable size.In addition, the contrast spike device in question is spiked into the contrast bottle and is connected proximal to the contrast controller.The contrast controller device has 2 in-line check valves that would impede any loose foreign matter from flowing into the contrast controller chamber.This has been deemed to be an isolated incident and the packaging department has been made aware of this report.((b)(4)).

• Brand Name: ANGIODYNAMICS
• Type of Device: CONTRAST CONTROLLER SPIKE ASSEMBLY
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• Manufacturer (Section G): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• Manufacturer Contact: law ryan ; 10 glens falls technical park; glens falls, NY 12801 ; 5187424488
• MDR Report Key: 6722051
• MDR Text Key: 80510087
• Report Number: 1317056-2017-00055
• Device Sequence Number: 1
• Product Code: IZI
• UDI-Device Identifier: H965904000391
• UDI-Public: H965904000391
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K903493
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/28/2017

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
• Device Operator: Other
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: H965904000391
• Device Lot Number: 5155600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/21/2017
• Initial Date FDA Received: 07/18/2017
• Supplement Dates Manufacturer Received: 06/21/2017
• Supplement Dates FDA Received: 09/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1