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

Model Number AX-80075

Device Problems Nonstandard Device (1420); Contamination /Decontamination Problem (2895)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/20/2021

Event Type  malfunction  

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 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).

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 Description

This is a follow-up for the initially filed mdr.

Event Description

This is a second follow-up for mdr (3006575795-2021-00052).

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
• Type of Device: 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
• MDR Text Key: 280680219
• Report Number: 3006575795-2021-00052
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00814371020518
• UDI-Public: 00814371020518
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132841
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 12/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1