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

Model Number A2-80071-DF

Device Problems Device Operates Differently Than Expected (2913); Physical Property Issue (3008)

Patient Problem Not Applicable (3189)

Event Date 12/19/2016

Event Type  malfunction  

Manufacturer Narrative

The failed iv sets have been sent to the contract supplier for evaluation on 01/03/2017.The manufacturer is still waiting for the results.A quality alert has been sent to the contract supplier to address the issue proactively on 01/03/2017.

Event Description

The user reported iv sets leaking at the air vent.The users had been opening the vent, when it was not necessary, while priming the line with standard iv bags, not bottles.Then they were unable to close the vent back up tightly, and the air vent does not close tightly.The sets were primed with chemo, taxol.No patient was involved, only the pharmacist was involved when priming.

Manufacturer Narrative

Zyno medical received the investigation report from the contract supplier on 06/05/2017.The user-reported leaking issue is confirmed.Corrective actions have been taken to address the manufacturing deficiency identified.

Event Description

This is a follow-up for the initially filed mdr (3006575795-2017-00004).

• Brand Name: ZYNO MEDICAL ADMINISTRATION SET FOR Z-800 INFUSION PUMP
• Type of Device: IV ADMINISTRATION SET
• Manufacturer (Section D): ZYNO MEDICAL LLC.; 177 pine street; natick MA 01760
• Manufacturer Contact: chaoyoung lee ; 177 pine street; natick, MA 01760 ; 5086502008
• MDR Report Key: 6244078
• MDR Text Key: 64593928
• Report Number: 3006575795-2017-00004
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00814371020167
• UDI-Public: 00814371020167
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132841
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A2-80071-DF
• Device Lot Number: 1410004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1