MAUDE Adverse Event Report: ZYNO MEDICAL LLC ZYNO MEDICAL ADMINISTRATION SET FOR Z-800 INFUSION PUMP; IV ADMINISTRATION SET

Model Number	A2-80072F
Medical Device Problem Codes	Leak/Splash (1354); Mechanical Problem (1384); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer is still waiting for the arrival of the device.
Event or Problem Description
A distributor forwarded an message from a representative at the user facility reported a leaking issue with the device to zyno medical on (b)(6) 2018: "we had an incident where the chemotherapy was leaking from the filter part of the tubing.Patient noticed leaking but was not exposed externally from leakage.No injuries to patient or staff.Leaking just at the filter site and yes approximately 200 cc was delivered to patient iv already." the event date was "(b)(6) 2018" and the solution used during the event was "etoposide in 50 cc nss over 1 hour".The affected set was captured at the user facility and will be return to zyno medical for investigation.The contract supplier of the affected device is (b)(4).
Event or Problem Description
This is a follow-up for the initially filed mdr (3006575795-2018-00025).
Additional Manufacturer Narrative
A quality alert was sent to becton dickinson on 03/19/2018.The affected administration set was received by the contract manufacturer becton dickinson on 05/09/2018.Becton dickinson did a preliminary investigation of the affected administration set and identified the leak at the filter.Becton dickinson deemed that the root cause was supplier related.The supplier was contacted by becton dickinson for a formal evaluation on 06/05/2018.Zyno medical receives the final evaluation report from bd on (b)(4) 2018.This evaluation identified that the filter presented leak at the housing and the vent, which suggested that the parts were over pressurized at point of use.The leak testing is being performed at becton dickinson incoming inspection area to the filters received from the supplier in order to identify potential leak issues.

• Brand Name: ZYNO MEDICAL ADMINISTRATION SET FOR Z-800 INFUSION PUMP
• Common Device Name: IV ADMINISTRATION SET
• Manufacturer (Section D): ZYNO MEDICAL LLC; 177 pine street; natick MA 01760
• MDR Report Key: 7247348
• Report Number: 3006575795-2018-00025
• Device Sequence Number: 997598
• Product Code: FPA
• UDI-Device Identifier: 00814371020129
• UDI-Public: 00814371020129
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K132841
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2018

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: 06/01/2019
• Device Model Number: A2-80072F
• Device Lot Number: 16065913
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2018
• Supplement Date Received by Manufacturer: 08/23/2018
• Initial Report FDA Received Date: 02/07/2018
• Supplement Report FDA Received Date: 08/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1