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

Model Number	80071-DF
Medical Device Problem Codes	Fluid/Blood Leak (1250); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The samples have not been returned for evaluation yet.
Event or Problem Description
On (b)(6) 2020, a distributor of zyno medical reported a complaint.A user facility representative contacted the distributor on (b)(6) 2020 and stated that "an administration set model a2-80071-df lot 20036759 was leaking at the filter." the set was discarded and will not be returned.A sample from the same lot will be returned.A patient was involved but was not harmed or injured.The device operator was a registered nurse.The medication being infused was unknown.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 (3006575795-2020-00035).
Additional Manufacturer Narrative
On 11/10/2020, zyno medical sent a quality alert to the contract manufacturer about the complaint.On 11/11/2020, the distributor notified zyno medical that the customer will not be sending any samples for investigation.The reported issue couldn't be confirmed.
Additional Manufacturer Narrative
The contract manufacturer provided a response letter with investigation results on (b)(6) 2020.A gemba walk was carried out to identify possible findings in the manufacturing process.No opportunities were found in the manufacturing process that could cause the failure mode.Leak tests were performed using unused samples from the same lot # retained by the contract manufacturer.No leaking was observed.The failure mode could not be confirmed.No corrective or preventative actions were performed since the root cause could not be determined.
Event or Problem Description
This is the second follow-up for the initially filed mdr (3006575795-2020-00035).
Additional Manufacturer Narrative
Correction: in the mdr 3006575795-2020-00035_complaint 2020v-030 follow up 2, it was reported that "leak tests were performed using unused samples from the same lot # retained by the contract manufacturer." this information is not correct.On 01/15/2021, the contract manufacturer confirmed that the leaking test report provided is part of the device history record (dhr), which was generated prior to the product release.The dhr review confirmed that the lot passed the leaking test during the manufacturing.
Event or Problem Description
This is the third follow-up for the initially filed mdr (3006575795-2020-00035).

• 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
• MDR Report Key: 10677357
• Report Number: 3006575795-2020-00035
• Device Sequence Number: 13562283
• Product Code: FPA
• UDI-Device Identifier: 00814371020075
• UDI-Public: 00814371020075
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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,Followup
• Report Date (Section B): 01/20/2021

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: 03/22/2023
• Device Model Number: 80071-DF
• Device Catalogue Number: A2-80071-DF
• Device Lot Number: 20036759
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2020
• Supplement Date Received by Manufacturer: 11/11/2020; 12/23/2020; 01/15/2021
• Initial Report FDA Received Date: 10/14/2020
• Supplement Report FDA Received Date: 11/17/2020; 01/15/2021; 01/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1