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

Model Number	FE01
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/30/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The user didn't send the failed iv set to the manufacturer for evaluation.The initial determination by following the company procedures was that this complaint did not constitute an mdr reportable event.This mdr is filed retrospectively as a corrective action to address one of the fda inspection observation made on 08/11/2016.Device not returned to manufacturer.
Event or Problem Description
The user reported an issue of "leaking out of the filter chamber even when the tuning and roller clamp are closed".No patient was injured or harmed.
Additional Manufacturer Narrative
Zyno medical has received the unused administration sets from the same lot from the user and performed testing on (b)(6) 2017.The user-reported leaking issue at the filter chamber could not be duplicated, and thus zyno medical was unable to confirm the complaint.Details of the testing can be found in the attached report.
Event or Problem Description
This is a follow-up for the initially filed mdr (3006575795-2017-00018).

• 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: 6258314
• Report Number: 3006575795-2017-00018
• Device Sequence Number: 18922169
• Product Code: FPA
• UDI-Device Identifier: 00814371020365
• UDI-Public: 00814371020365
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2017

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: 10/01/2017
• Device Model Number: FE01
• Device Lot Number: 1410010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2016
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/17/2017
• Supplement Report FDA Received Date: 10/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1