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	Not Applicable (3189)
Date of Event	02/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer is currently waiting for the arrival of the iv set.
Event or Problem Description
The user reported leakage of the iv set.No patient harm or injury occurred in this case.
Additional Manufacturer Narrative
The user-reported leaking issue was not confirmed.Zyno medical performed testings on 10 unopened samples of returned iv set with the same lot number on 06/14/2017, and the investigation report is attached.(b)(4).
Event or Problem Description
This is a follow-up for the initially filed mdr (3006575795-2017-00070).

• 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: 6379119
• Report Number: 3006575795-2017-00070
• Device Sequence Number: 773229
• Product Code: FPA
• UDI-Device Identifier: 00814371020112
• UDI-Public: 00814371020112
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2017

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: A2-80072
• Device Lot Number: 1604008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/27/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/04/2017
• Supplement Report FDA Received Date: 06/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1