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	06/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zyno medical is currently waiting for the investigation results from the service provider.
Event or Problem Description
On 07/20/2020, a distributor of zyno medical reported a complaint.A user facility representative contacted the distributor stating that an administration set model a2-80071-df lot 18036934 was leaking at the filter.A patient was involved but not harmed.The device operator was a registered nurse.The medication being infused was unknown.The contract manufacturer of the affected device is (b)(4).
Additional Manufacturer Narrative
Zyno medical llc received the administration set evaluation report from the service provider on 11/05/2020.An unused sample for the same lot of the affected administration set was tested.Visual inspection confirmed that there was no defect or damage to the set.An infusion was completed with no visible leak noticed from the filter.The administration set passed the test and meets specifications.The reported issue was not confirmed.
Event or Problem Description
This is a follow-up for the initially filed mdr (mdr 3006575795-2020-00008).
Event or Problem Description
This is a second follow-up for the initially filed mdr (3006575795-2020-00008).
Additional Manufacturer Narrative
The contract manufacturer provided the investigation report on 03/16/2021.The actual device was tested and the leak in the filter was confirmed from the weld area.The part did go through the welding operation.The weld line was visible around the part, while the area of the leak was not welded at the time of testing.With the part being 3 years old, there was no way to adequately identify what could have caused the filter to un-weld.A dhr review was conducted, and no changes/rejections were identified that could have caused a weaker weld.The root cause could not be established.

• 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: 10377168
• Report Number: 3006575795-2020-00008
• Device Sequence Number: 1896577
• 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): 03/17/2021

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2020
• Supplement Date Received by Manufacturer: 11/05/2020; 03/16/2021
• Initial Report FDA Received Date: 08/06/2020
• Supplement Report FDA Received Date: 11/17/2020; 03/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1