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

Model Number	AX-80075
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zyno medical is waiting for the arrival of the affected device.
Event or Problem Description
On 12/23/2021, zyno medical received a complaint from a user facility representative.It was reported that "an administration set model ax-80075 lot 2109002 set had a particle in the drip chamber after completing a chemo therapy treatment." a patient was involved but was not harmed or injured.The device operator was a registered nurse.The medication being infused was unknown.The contract manufacturer of the affected device is podo xingda (b)(4) medical co.Ltd.
Additional Manufacturer Narrative
The service provider provided the investigation report on 03/04/2022.The actual device was inspected.A small piece of circle shaped white object was observed inside the drip chamber.The reported issue is confirmed but the root cause cannot be identified.
Event or Problem Description
This is a follow-up for the initially filed mdr (3006575795-2021-00059).
Event or Problem Description
This is the second follow-up for the initially filed mdr (3006575795-2021-00059).
Additional Manufacturer Narrative
The contract manufacturer provided the investigation report on 05/19/2022.The actual device was inspected.The white particle was confirmed to be an air intake film, which is a component of the administration set.It is believed to be a manual assembly problem during the manufacturing process.Operators at the production site were notified about this complaint and they have been required to pay attention during the production operation.

• 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
• Manufacturer (Section G): ZYNO MEDICAL, LLC; 177 pine street; natick MA 01760
• Manufacturer Contact: chaoyoung lee ; 177 pine street; natick, MA 01760
• MDR Report Key: 13208391
• Report Number: 3006575795-2021-00059
• Device Sequence Number: 4564263
• Product Code: FPA
• UDI-Device Identifier: 00814371020518
• UDI-Public: 00814371020518
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K132841
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/20/2022

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: 09/29/2024
• Device Model Number: AX-80075
• Device Lot Number: 2109002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2021
• Supplement Date Received by Manufacturer: 03/04/2022; 05/19/2022
• Initial Report FDA Received Date: 01/10/2022
• Supplement Report FDA Received Date: 03/25/2022; 05/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown