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

Model Number	B2-70072
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Return of the device has been requested.As of the date of this report, device has not been returned.
Event or Problem Description
Customer reported "small hole in the chamber and caused immediate leaking".Medication being infused was unknown.No patient injury reported.
Additional Manufacturer Narrative
5 unused samples from lot 23045125 were tested and no small holes were found on the sets.There were small blemishes, but none of them leaked during testing.Reported issue is not confirmed.

• 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: lorraine hanley ; 177 pine street; natick, MA 01760 ; 5083158230
• MDR Report Key: 17270443
• Report Number: 3006575795-2023-00049
• Device Sequence Number: 15431667
• Product Code: FPA
• UDI-Device Identifier: 00814371020198
• UDI-Public: 00814371020198
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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: Consumer,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2023

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: B2-70072
• Device Catalogue Number: B2-70072
• Device Lot Number: 23045125
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/20/2023
• Supplement Date Received by Manufacturer: 06/20/2023
• Initial Report FDA Received Date: 07/06/2023
• Supplement Report FDA Received Date: 09/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown