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

Model Number	AA80075
Medical Device Problem Codes	Fluid/Blood Leak (1250); Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected set is not yet returned to the distributor.
Event or Problem Description
A distributor reported a leaking issue of an administration set to zyno medical on (b)(6) 2019.The distributor received an email from the initial reporter on (b)(6) 2019, stating that the administration set tubing was leaking from the air vent on the drip chamber.The medication being infused was doxorubicin.There was no patient injury and no patient information was provided to zyno medical.The contract supplier of the affected device is (b)(4).
Additional Manufacturer Narrative
The leaking issue was not confirmed.The service provider of zyno medical performed the testing on three returned devices from the same lot as the affected device on 04/17/2019.No leaking was observed on the samples tested.
Event or Problem Description
This is a follow up report for the initially submitted mdr (3006575795-2019-00001).

• Brand Name: ZYNO MEDICAL ADMINISTRATION SET FOR Z-800 INFUSION PUMP
• Common Device Name: IV ADMINISTRATION SET
• Manufacturer (Section D): ZYNO MEDICAL LLC; 177 pine street; natick MA 01760
• MDR Report Key: 8232389
• Report Number: 3006575795-2019-00001
• Device Sequence Number: 215330
• Product Code: FPA
• UDI-Device Identifier: 00814371020600
• UDI-Public: 00814371020600
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K120685
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2019

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: 03/06/2023
• Device Model Number: AA80075
• Device Lot Number: 123363KS
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2019
• Supplement Date Received by Manufacturer: 04/17/2019
• Initial Report FDA Received Date: 01/09/2019
• Supplement Report FDA Received Date: 05/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1