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

Model Number	AX-80071-D
Medical Device Problem Codes	Leak/Splash (1354); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Since no affected sets were captured to be sent back to the manufacturer for evaluation, zyno medical reached out to the initial reporter about sending in unused sets for evaluation on (b)(6) 2018.
Event or Problem Description
A rn at a user facility reported a leaking issue at the drip chamber of the administration set on (b)(6) 2018.Approximately 5 sets experienced the issue of leaking at the drip chamber near the bottom where it connects to the tubing since (b)(6) 2018.No affected set was captured and all affected sets were disposed by a nurse that experienced this issue.Medications used during this incident were ns, tyfabri and ocrevus.The contract manufacturer of the administration set is (b)(4).No patient jury or harm was reported.
Additional Manufacturer Narrative
The customer was contacted three times on (b)(6) 2018, (b)(6) 2018 and (b)(6) 2018 in regards to returning any unused iv sets she may have.No response was ever received.The reported leaking issue was not confirmed.
Event or Problem Description
This is a follow-up for the initially filed mdr (3006575795-2018-00039).

• 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: 7480636
• Report Number: 3006575795-2018-00039
• Device Sequence Number: 1417825
• Product Code: FPA
• UDI-Device Identifier: 00814371020440
• UDI-Public: 00814371020440
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2018

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: Nurse
• Device Expiration Date: 08/01/2019
• Device Model Number: AX-80071-D
• Device Lot Number: 1606005
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2018
• Supplement Date Received by Manufacturer: 06/12/2018
• Initial Report FDA Received Date: 05/02/2018
• Supplement Report FDA Received Date: 06/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1