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

Model Number	A2-80070
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	10/20/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Ten unopened iv sets from the same lot number were evaluated on 12/08/2016.No leaking was observed for the iv sets tested.The user reported issue was not duplicated.A quality alert has been sent to the contract supplier on 01/10/2017 proactively.Upon receiving the complaint, it was initially determined as not reportable by the manufacturer.During the final review of the complaint file by quality/management, it was determined as mdr reportable on 12/15/2016.
Event or Problem Description
The user reported that "i've had to pull a total of 1305 admin sets out of use (a2-80070) because we have had several of the sets (lot 1606002) leak during infusion." patients were involved but no injury or harm.The leaking came from the greenish port (air vent) just under the spike.

• 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: 6244079
• Report Number: 3006575795-2017-00003
• Device Sequence Number: 19021608
• Product Code: FPA
• UDI-Device Identifier: 00814371020051
• UDI-Public: 00814371020051
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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
• Report Date (Section B): 01/11/2017

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 Model Number: A2-80070
• Device Lot Number: 1606002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2016
• Initial Report FDA Received Date: 01/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1