MAUDE Adverse Event Report: ZYNO MEDICAL, LLC ZYNO MEDICAL IV ADMINISTRATION SETS

Model Number	AX-80075
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It is determined to be a serile packaging issue where end user reported that there is hair in the bag which is a sterile product.All the information and pictures provided by the end user were reviewed.A capa has been opened in order to fully diagnose and address the root cause of the reported event.
Event or Problem Description
On (b)(6) 2024 intuvie received a complaint via fda's medwatch program where fda attached the mdr report submitted by the initial reporter from cancer and hematology centers of western michigan.Mdr report indicates that the there is a hair in bag noticed where it is a sterile product.Also additional documents were attached for reference.

• Brand Name: ZYNO MEDICAL IV ADMINISTRATION SETS
• Common Device Name: IV ADMINISTRATION SETS
• 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: frederick lee ; 177 pine street; natick, MA 01760 ; 5086502007
• MDR Report Key: 19166813
• Report Number: 3006575795-2024-00140
• Device Sequence Number: 12599946
• Product Code: FPA
• UDI-Device Identifier: 00814371020518
• UDI-Public: 00814371020518
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K130690
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/23/2024

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 Model Number: AX-80075
• Device Catalogue Number: AX-80075
• Device Lot Number: 2302002
• 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: 04/02/2024
• Initial Report FDA Received Date: 04/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown