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

Model Number	B2-70071-DF
Medical Device Problem Codes	Leak/Splash (1354); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer is currently waiting for the arrival of the device.
Event or Problem Description
The user reported an issue with the administration set."taxol was infusing through the filtered tubing and a slow drip of drug was noticed to be coming out of the y-site.We caught it early in the infusion and changed the tubing."no patient injury or harm occurred for this case.The event date and patient information are unknown.
Additional Manufacturer Narrative
The user reported y-site leaking issue was confirmed.The quality alert was sent out to the contract supplier (b)(4) on 09/01/2017.The investigation was performed by the contract supplier and the report was returned to zyno medical on 02/02/2018.(b)(4).
Event or Problem Description
This is a follow-up for the initially filed mdr (3006575795-2017-00263).

• 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: 6842330
• Report Number: 3006575795-2017-00263
• Device Sequence Number: 10953009
• Product Code: FPA
• UDI-Device Identifier: 00814371020167
• UDI-Public: 00814371020167
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 08/30/2017

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: B2-70071-DF
• Device Lot Number: 16127525
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2017
• Supplement Date Received by Manufacturer: 02/02/2018
• Initial Report FDA Received Date: 09/05/2017
• Supplement Report FDA Received Date: 02/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1