MAUDE Adverse Event Report: ZYNO MEDICAL, LLC ZYNO; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	BX-70071-DF
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned bx-70071-df administration set associated with this complaint was received by intuvie on 12/01/2025 under rma 17074.Evaluation and testing were completed on 12/09/2025, during which the reported issue was confirmed.A visual inspection of the sterile pouch verified the presence of a hair located partially inside the packaging, consistent with the customer¿s initial report.This complaint involves one affected unit from lot 2502034.A review of complaint history for this lot found no additional complaints.According to the lot documentation and certificate of conformance/certificate of sterilization provided by the contract manufacturer, the lot ((b)(4) units) was manufactured on 03/20/2025 and sterilized on 03/31/2025, with no nonconformities noted during processing or release.The investigation into the source of the hair is ongoing.Any new findings will be submitted in a follow-up mdr.
Event or Problem Description
Intuvie received a report from right way medical stating that synchrony pharmacy found a hair ¿half inside and half outside¿ in the sterile package of one bx-70071-df administration set from lot 2502034.The issue was identified prior to use, and no patient involvement or adverse event occurred.

• Brand Name: ZYNO
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• 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: fred lee ; 177 pine street; natick, MA 01760 ; 5086502007
• MDR Report Key: 23759871
• Report Number: 3006575795-2025-00745
• Device Sequence Number: 18664747
• Product Code: FPA
• UDI-Device Identifier: 00814371020549
• UDI-Public: (01)00814371020549(17)260319(10)2502034
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K120685
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/09/2025

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: Lay User/Patient
• Device Expiration Date: 03/19/2026
• Device Model Number: BX-70071-DF
• Device Catalogue Number: BX-70071-DF
• Device Lot Number: 2502034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2025
• Initial Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2025
• 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