MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYNAMICS; MANIFOLD

Catalog Number	H965700382001
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It has been indicated that the device from the reported event will be returned to angiodynamics for evaluation, however it has not yet arrived.Upon receipt of the sample and completion of the investigation, a supplemental medwatch will be submitted.(b)(4).
Event or Problem Description
As reported by angiodynamics' distributor in (b)(6), "air leakage was observed through the manifold by bubbles passing through the ports." no patient injury was reported.It has been indicated that the manifold sample will be returned to angiodynamics.
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 manifold product family and the failure mode "air bubbles noted." no adverse trend was identified.In addition, this is the only reported complaint for this failure mode in the past 15 months for the manifold product family.No sample was returned to angiodynamics, so a device evaluation was not possible.Although a video taken during a procedure was provided, this proved to be inconclusive regarding the event.A possible root cause may be that the end user did not adequately secure connections between the manifold and the device to which it was connected, or that they not "finger tightened" prior to use as it is stated in the dfu provided to the customer with the reported device.The dfu contains the following statements, "all connections should be finger tightened.Over tightening can cause cracks and leaks to occur that could result in embolism and or exposure to biohazards." (pr (b)(4)).

• Brand Name: ANGIODYNAMICS
• Common Device Name: MANIFOLD
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 7842712
• Report Number: 1317056-2018-00166
• Device Sequence Number: 1271779
• Product Code: DTL
• UDI-Device Identifier: H965700382001
• UDI-Public: H965700382001
• Combination Product (Y/N): N
• Initial Reporter Country: LE
• PMA/510(K) Number: K782095
• 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): 11/29/2018

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: 10/31/2019
• Device Catalogue Number: H965700382001
• Device Lot Number: 5090744
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/07/2018
• Supplement Date Received by Manufacturer: 08/07/2018
• Initial Report FDA Received Date: 09/04/2018
• Supplement Report FDA Received Date: 11/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR