MAUDE Adverse Event Report: ZYNO MEDICAL, LLC ADMINISTRATION SET FOR AMBULATORY INFUSION PUMP; IV ADMISTRATION SET

Model Number	BX70072
Medical Device Problem Codes	Mechanical Problem (1384); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected bags had not been returned, they were requested to be return for further investigation.Testing results were reviewed.It was discovered that there were discrepancies in the test records.Ncr (b)(4) had been initiated to address the discrepancies.This mdr will be reopened and updated in the event the affected bags involved or additional information becomes available.
Event or Problem Description
On (b)(6) 2024, zyno received a report from the customer that when priming the tubing even after being carefully it generates a lot of air bubbles.The nurse reported that 4 pumps had allowed the air past the pump chamber.Fortunately, the pump beeped that the infusion was completes before air got to the patient.No patient injury/harm reported.
Additional Manufacturer Narrative
This supplement serves as a correction as part of our retrospective 2024 compliant remediation.Section d-suspect medical device: the iv set model needed to be corrected from bx-70072 to be an unknown iv set to match what's been reported in the case.It is unknown which iv set was used.Reference to complaint #(b)(4).

• Brand Name: ADMINISTRATION SET FOR AMBULATORY INFUSION PUMP
• Common Device Name: IV ADMISTRATION 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: frederick lee ; 177 pine street; natick, MA 01760 ; 5086502008
• MDR Report Key: 19605988
• Report Number: 3006575795-2024-00367
• Device Sequence Number: 20422940
• Product Code: FPA
• UDI-Device Identifier: 00814371020570
• UDI-Public: 00814371020570
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2025

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: Health Professional
• Device Model Number: BX70072
• Device Lot Number: 2207006
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/25/2024
• Supplement Report FDA Received Date: 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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