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	01/12/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The user-reported leakage issue was not duplicated using substituted iv sets.The used iv set returned from the user was contaminated with biohazard.Therefore,unopened iv sets from the same lot number (returned by the user) were evaluated.No back check valve failure was observed for the twenty iv sets tested.(b)(4).
Event or Problem Description
The customer reported a back check valve failure."the nurse squeezed the primary saline bag to back prime the secondary drug bag.When the nurse let go of the primary bag, the fluid in the secondary bag backed up in the primary iv set." the user "also had two back check valve failure last week." no patient injury or harm was involved in this case.

• 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: 6234094
• Report Number: 3006575795-2016-00146
• Device Sequence Number: 13559510
• Product Code: FPA
• UDI-Device Identifier: 00814371020112
• UDI-Public: 00814371020112
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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
• Report Date (Section B): 01/09/2017

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: 10/01/2017
• Device Model Number: A2-80072
• Device Lot Number: 14106187
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1