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

Model Number	B2-70071-DF120
Medical Device Problem Codes	Leak/Splash (1354); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer is still waiting for the return of the device.
Event or Problem Description
A distributor reported a leaking issue to zyno medical on 01/11/2018.The following information was forwarded from the user facility to the distributor on 01/11/2018: "the patient was admitted on (b)(6) 2018 so i am assuming the tubing was delivered at the same time.The problem is the tubing was leaking at the filter.The tubing was changed 3 times.I only have 1 left of the original tubing, the rest was thrown away yesterday when we received a new batch.There are a couple numbers on the package with expiration of 09/2019.This problem has been reported to the tubing company.They conducted their own tests and found zero tubing that leaked." zyno medical followed up with the representative at the user facility on 01/11/2018 and obtained the response: "there was no injury to the patient, the iv tubing was leaking near the filter on a couple of the tubing's in this batch.I believe it happened on a couple different days.Yes, i have one set i was able to grab".No patient injury occured for this event.The event date was reported as (b)(6) 2018.
Additional Manufacturer Narrative
Zyno medical has sent am unused set and a quality alert to the contract supplier becton dickinson on 01/30/2018.The contract supplier provided the investigation report to zyno medical on 02/20/2018.The user-reported leaking issue could not be confirmed.Details of the result can be found in (b)(4).
Event or Problem Description
This is a follow-up for the initially filed mdr.

• 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: 7207886
• Report Number: 3006575795-2018-00013
• Device Sequence Number: 19126076
• Product Code: FPA
• UDI-Device Identifier: 00814371020174
• UDI-Public: 00814371020174
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K132841
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2018

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 Model Number: B2-70071-DF120
• Device Catalogue Number: B2-70071-DF120
• Device Lot Number: 16095981
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2018
• Supplement Date Received by Manufacturer: 02/19/2018
• Initial Report FDA Received Date: 01/19/2018
• Supplement Report FDA Received Date: 02/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1