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 Codes	Nonstandard Device (1420); Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The service provider provided the investigation report on 10/22/2021.The actual device was inspected.Visual inspection confirmed there is an unknown particle in the spike.The reported issue is confirmed.On 10/26/2021, zyno medical notified the contract manufacturer about the complaint.The affected device will be sent to the contract manufacturer for further evaluation.
Event or Problem Description
On 10/20/2021, a distributor of zyno medical reported a complaint.A user facility representative contacted the distributor and stated that "an administration set model ax-80075 lot 2009003 set had an unknown particle in the spike.Particle was in the fluid path." 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 (b)(4).
Additional Manufacturer Narrative
On 11/14/2021, the contract manufacturer provided an evaluation report.The brown particle was confirmed to be injection paste from the injection molding process.The long-term high-temperature melt was not cleaned thoroughly during the maintenance, which formed brown particles at the end of the injection mold.The complaint is an isolated event.A quality alert was issued to inform the maintenance and operation personnel at the production site.
Event or Problem Description
This is a follow-up for the initially filed mdr.
Event or Problem Description
This is a second follow-up for mdr (3006575795-2021-00052).
Additional Manufacturer Narrative
On 12/09/2021, the contract manufacturer confirmed that the affected device didn't meet the specification.The brown particle was missed during the visual inspection.

• 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: 12790466
• Report Number: 3006575795-2021-00052
• Device Sequence Number: 4840349
• Product Code: FPA
• UDI-Device Identifier: 00814371020518
• UDI-Public: 00814371020518
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/15/2021

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: 08/10/2024
• Device Model Number: AX-80075
• Device Catalogue Number: AX80075
• Device Lot Number: 2009003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2021
• Supplement Date Received by Manufacturer: 11/14/2021; 12/09/2021
• Initial Report FDA Received Date: 11/10/2021
• Supplement Report FDA Received Date: 12/08/2021; 12/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2021
• 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