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

Model Number	AX80075
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	08/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zyno medical is waiting for the arrival of the affected iv set to perform the investigation.
Event or Problem Description
On (b)(6) 2019, a distributor of zyno medical reported a complaint.A user facility representative contacted the distributor stating that "(b)(6) has a leaking secondary tubing ax-80075 lot number: 1807005.I am returning it to you, it does have chemo in it (dacarbazine).The tubing was leaking at the blue air vent.It happened (on) (b)(6) 2019 at 3:00 pm." no patient harm or injury involved.The distributor followed up for further information (including to clarify what is meant by blue air vent-- is it green vent on the drip chamber? or is it the blue back check valve?) and is awaiting for a response.
Additional Manufacturer Narrative
The affected set returned from the customer was tested by the service provider on 10/04/2019.The reported leaking issue couldn't be repeated.On visual inspection, no abnormalities were observed on the iv set.During the testing, no leaking issue was observed anywhere on the iv set.The complaint couldn't be confirmed.
Event or Problem Description
This is a follow-up for the initially filed mdr (3006575795-2019-00026).The service provider confirmed on 10/24/2019 that the customer never provided any further clarification regarding the event.

• Brand Name: ZYNO MEDICAL ADMINISTRATION SET FOR Z-800 INFUSION PUMP SYSTEM
• Common Device Name: IV ADMINISTRATION SET
• Manufacturer (Section D): ZYNO MEDICAL, LLC; 177 pine street; natick MA 01760
• MDR Report Key: 9078375
• Report Number: 3006575795-2019-00026
• Device Sequence Number: 14245385
• Product Code: FPA
• UDI-Device Identifier: 00814371020518
• UDI-Public: 00814371020518
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K132841
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2019

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: 08/23/2021
• Device Model Number: AX80075
• Device Lot Number: 1807005
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 10/24/2019
• Initial Report FDA Received Date: 09/17/2019
• Supplement Report FDA Received Date: 10/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1