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

Model Number	A2-80072
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/12/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A quality alert has been sent to the contract supplier regarding this issue.The manufacturer is still waiting for the investigation results.The initial determination by following the company procedures was that this complaint did not constitute an mdr reportable event.This mdr is filed retrospectively as a corrective action to address one of the fda inspection observation made on 08/11/2016.
Event or Problem Description
The user reported that she had multiple back check valve failure with a2-80072 lot 16016108 iv sets.Patients were involved but not harmed.
Additional Manufacturer Narrative
The user-reported back-check valve issue could not be confirmed.A total of 60 administration sets (lot number 16016108) were received by zyno medical on 05/19/16.As of 09/26/17, these iv sets could not be located within the facility of zyno medical natick.Thus, no actions could be taken by zyno medical to conduct an evaluation for this complaint.Zyno medical closed this complaint on 10/02/2017.
Event or Problem Description
This is a follow-up for the initially filed mdr (3006575795-2017-00024).

• 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: 6304802
• Report Number: 3006575795-2017-00024
• Device Sequence Number: 18960846
• Product Code: FPA
• UDI-Device Identifier: 00814371020112
• UDI-Public: 00814371020112
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Initial Reporter Occupation: Nurse
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/01/2019
• Device Model Number: A2-80072
• Device Lot Number: 16016108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2016
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2016
• Supplement Date Received by Manufacturer: 09/26/2017
• Initial Report FDA Received Date: 02/06/2017
• Supplement Report FDA Received Date: 10/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1