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

Model Number	A2-80071-DF
Medical Device Problem Codes	Fluid/Blood Leak (1250); Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zyno medical is waiting for the arrival of the affected device.
Event or Problem Description
On 6/8/2020, a distributor of zyno medical reported a complaint.A user facility representative contacted the distributor on 6/1/2020 stating that "an administration set model ax-80071-df lot 18036934 set was leaking at the filter." a patient was involved, but was not harmed or injured.The device operator was a registered nurse.Medication infused gammagard.The distributor representative later made a correction that the model number is a2-80071-df.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.
Additional Manufacturer Narrative
On 07/20/2020, the distributor informed zyno medical that the end user had discarded the affected administration set.No administration set will be returned for investigation.Scar ((b)(4)) was issued to the contract manufacturer regarding the filter leaking issue on 06/12/2020.Currently, zyno medical is waiting for the investigation results of the scar.
Additional Manufacturer Narrative
The contract manufacturer provided response to scar 2020-001 on (b)(6) 2020.The scar form was reviewed and accepted by zyno on (b)(6) 2020.The filter supplier performed a dhr review of affected lots and found no nonconformance associated with these lots internally.With no samples available, investigation cannot be completed.Therefore, no specific root cause can be determined.As part of the continuous improvements, actions to reduce/eliminate leak failure have been implemented by the filter supplier from (b)(6) 2019 to (b)(6) 2020.
Event or Problem Description
This is the second follow-up for the initially filed mdr (3006575795-2020-00006).

• 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
• MDR Report Key: 10209710
• Report Number: 3006575795-2020-00006
• Device Sequence Number: 11580861
• Product Code: FPA
• UDI-Device Identifier: 00814371020075
• UDI-Public: 00814371020075
• Combination Product (Y/N): N
• 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: distributor,health profession
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/20/2020

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: 03/26/2021
• Device Model Number: A2-80071-DF
• Device Catalogue Number: A2-80071-DF
• Device Lot Number: 18036934
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2020
• Supplement Date Received by Manufacturer: 07/20/2020; 10/20/2020
• Initial Report FDA Received Date: 06/29/2020
• Supplement Report FDA Received Date: 08/06/2020; 11/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1