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

Model Number	A2-80071-DF
Medical Device Problem Codes	Leak/Splash (1354); Mechanical Problem (1384); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected device was not captured at the user facility, and thus zyno medical was unable to confirm the reported issue.
Event or Problem Description
A distributor forwarded the message from a representative at the user facility reporting a filter leaking issue to zyno medical on 01/31/2018.The nurse at the user facility further updated that "we have been having some trouble with the filters on or 80071-df tubing.The filter makes a "snap" sound the then starts leaking (yes, the clamps are open!).A patient actually alerted the nurse she heard a "pop" and the nurse investigated and found cracked filter leaking.Pt was not injured.The set was not saved but will save any future ones to send back.Uncertain of exactly which package the mentioned tubing came from." no event date was provided by the initial reporter.The contract supplier of the affected device is becton dickinson.The distributor has confirmed that the model number of the affected set.
Additional Manufacturer Narrative
Zyno medical received an investigation report from the contract supplier of the affected device on 01/29/2019.The reported "filter leak" could not be confirmed, because the actual device was not returned for investigation.The supplier determined that the reported issue was an isolated event after performing a review of qn's and customer complaints from one year period and a review for devices with filters (lot: 133761) from the same lot as the one on the affected device.
Event or Problem Description
This is the follow up report for the initially submitted mdr (3006575795-2018-00024).

• 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: 7247344
• Report Number: 3006575795-2018-00024
• Device Sequence Number: 1185558
• Product Code: FPA
• UDI-Device Identifier: 00814371020075
• UDI-Public: 00814371020075
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K132841
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2018

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: 05/16/2020
• Device Model Number: A2-80071-DF
• Device Lot Number: 17056528
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2018
• Supplement Date Received by Manufacturer: 01/29/2019
• Initial Report FDA Received Date: 02/07/2018
• Supplement Report FDA Received Date: 01/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1