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

Model Number	B2-70071-D
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The end user provided images of the affected set showing the tubing was disconnected from the needless injection site.The complaint was confirmed.The affected set was discarded and not returned for evaluation.Therefore, no investigation could be performed.The root cause couldn't be established.
Event or Problem Description
On (b)(6) 2022, zyno medical received a complaint from a user facility representative.It was reported that "we had an incident happen where the tubing completely broke off at the hub.Luckily, the patient noticed quickly and not much drug was leaked." 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 becton, dickinson and company.
Event or Problem Description
This is a follow-up for the initially filed mdr.

• 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: 15294975
• Report Number: 3006575795-2022-00030
• Device Sequence Number: 15035452
• Product Code: FPA
• UDI-Device Identifier: 00814371020150
• UDI-Public: 00814371020150
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2022

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: 12/08/2024
• Device Model Number: B2-70071-D
• Device Catalogue Number: B2-70071-D
• Device Lot Number: 21125237
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2022
• Supplement Date Received by Manufacturer: 09/15/2022
• Initial Report FDA Received Date: 08/25/2022
• Supplement Report FDA Received Date: 09/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2022
• 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