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

Model Number	B2-70072
Medical Device Problem Codes	Fluid/Blood Leak (1250); Leak/Splash (1354); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer is still waiting for the arrival of the primary iv set.
Event or Problem Description
A (b)(6) medical employee reported an iv set leaking issue at a client's site.The leakage occurred from the air vent on the secondary set.This report is for the primary set associated with the secondary set.No patient harm or injury occurred for this case.
Additional Manufacturer Narrative
The affected administration set was not sent to zyno medical for investigation.Zyno medical's customer representative has reached out to the user on (b)(6) 2017 with no result.Thus zyno medical cannot confirm the issue.
Event or Problem Description
This is a follow-up for the initially filed mdr (3006575795-2017-00230).

• 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: 6645309
• Report Number: 3006575795-2017-00230
• Device Sequence Number: 13665361
• Product Code: FPA
• UDI-Device Identifier: 00814371020198
• UDI-Public: 00814371020198
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 09/22/2017

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: B2-70072
• Device Catalogue Number: B2-70072
• Device Lot Number: 17026879
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2017
• Supplement Date Received by Manufacturer: 06/08/2017
• Initial Report FDA Received Date: 06/15/2017
• Supplement Report FDA Received Date: 09/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1