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

Model Number	AA-80075
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	08/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer is waiting for the arrival of (b)(6) affected administration sets.Zyno medical has sent a quality alert to its contract supplier on (b)(6) 2017 regarding this complaint.
Event or Problem Description
The user reported an issue in which "the secondary set is allowing solution to pass when the roller clamp is closed".The user reported that "it seems, and i did witness this, that even when the clamp on the tubing is closed, once the bag has been spiked, the medication (whatever is in the bag) starts dripping.Again, this is occurring even though the roller clamp is closed.All of these incidents, which she said have been with just about every set she has using over the last few weeks, are from lot# 107272-ks.Patient was not directly involved and there were no injuries.Issue was noticed when tubing was connected to reservoir.(i) do not know exact date but she stated that it had been occurring for the last few days.".
Additional Manufacturer Narrative
The user-reported roller clamp issue was confirmed.Zyno medical initiated a supplier corrective action request (b)(4) for the contract supplier on (b)(6) 2017.The evaluation of the 8 affected administration set was received by zyno medical on (b)(6) 2017.The supplier performed the dhr review on the same lot and conducted the fishbone analysis, and the root cause was identified as the improper assembling process that led to the impact made on the roller.Corrective and preventive actions were made to improve the assembling process.The complaint was closed on (b)(6) 2017.
Event or Problem Description
This is a follow-up for the initially filed mdr (3006575795-20117-00266).

• 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: 6857576
• Report Number: 3006575795-2017-00266
• Device Sequence Number: 13705870
• Product Code: FPA
• UDI-Device Identifier: 00814371020600
• UDI-Public: 00814371020600
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 09/07/2017

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 Model Number: AA-80075
• Device Lot Number: 107272-KS
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2017
• Supplement Date Received by Manufacturer: 10/30/2017
• Initial Report FDA Received Date: 09/12/2017
• Supplement Report FDA Received Date: 11/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1