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 Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/06/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The leaking issue was confirmed.Affected iv sets are under recall #(b)(4).
Event or Problem Description
The user reported "we had a number of issues with the filter tubing leaking.After looking at the tubing, it seems to be leaking from where the two pieces come together, covering the filter ( i am not sure if these two pieces are glued together or what.)" the user also stated: "this event has happened several times, and has caused serious concerns within our company.This is not only a liability for us, but also a serious safety concern for patients, as well as employees.For our standpoint this product has proven to be inadequate, and we need swift resolution form zyno medical at this time.".

• 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: 6230427
• Report Number: 3006575795-2016-00018
• Device Sequence Number: 16287542
• Product Code: FPA
• UDI-Device Identifier: 00814371020075
• UDI-Public: 00814371020075
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 01/03/2017

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: 07/01/2017
• Device Model Number: A2-80071-DF
• Device Lot Number: 14075494
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2015
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2015
• Initial Report FDA Received Date: 01/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1