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

Model Number	AA-80075
Medical Device Problem Codes	Fluid/Blood Leak (1250); Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected set is to be evaluated by the service provider.
Event or Problem Description
A distributor reported a leaking issue of an administration set to zyno medical on (b)(4) 2018.The distributor received an email on (b)(4) 2018, stating that "upon starting emend, fluid noted to be dripping from iv tubing vent.Closed vent and infusion completed with no further issues." no patient injury was reported in this case.(b)(4).
Event or Problem Description
This is a follow-up for the initially filed mdr (3006575795-2018-00070).
Additional Manufacturer Narrative
The reported leaking issue could not be confirmed.On 04/15/2019, zyno medical was informed by the service provider that the affected administration set had been lost.The administration set was noted as having arrived on 12/10/2018 by an employee who is no longer working with this service provider.The current employee of the service provider conducted a thorough search of the premises but did not locate the affected device.

• 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: 8194300
• Report Number: 3006575795-2018-00070
• Device Sequence Number: 2141991
• Product Code: FPA
• UDI-Device Identifier: 00814371020600
• UDI-Public: 00814371020600
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K120685
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2018

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: AA-80075
• Device Catalogue Number: AA-80075
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2018
• Supplement Date Received by Manufacturer: 04/15/2019
• Initial Report FDA Received Date: 12/24/2018
• Supplement Report FDA Received Date: 04/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1