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	08/03/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint (b)(4) are from the same customer for the same issue.(b)(4) is the primary iv set.(b)(4) is the attached secondary iv set.The manufacturer suspect the issue is within the primary iv set, which may have a back check valve issue.The returned iv sets have been sent to the contract supplier for investigation on 09/12/2016.The manufacturer is still waiting for the results.Zyno medical submitted an e-mdr (3006575795-2016-00033_complaint (b)(4)) on 09/01/2016 through the fda's website and received the receipt.But due to some technical difficulties and confusion, the file didn't pass with all three acknowledgements.This is a re-submission regarding the same event.
Event or Problem Description
The customer is consistently getting 4-5 sets per box that are free flowing at the secondary connection.They think it's a problem with the upper y-site on the primary set, but it might be something with the secondary set.There was no patient injury or harm involved in this case.
Additional Manufacturer Narrative
Zyno medical has received the investigation report from the contract supplier on 05/01/2017.The back-flow issue was not confirmed.
Event or Problem Description
This is a follow-up for the initially filed mdr (3006575795-2016-00033).

• 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: 6233071
• Report Number: 3006575795-2016-00033
• Device Sequence Number: 16374093
• 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): 05/01/2017

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: 08/01/2018
• Device Model Number: A2-80072
• Device Lot Number: 15086784
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/09/2017
• Supplement Report FDA Received Date: 05/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1