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

Model Number	B2-70071-DF-120
Medical Device Problem Codes	Fluid/Blood Leak (1250); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer is currently waiting for the arrival of the iv set.A quality alert has been sent to the contract supplier on 06/20/2017.
Event or Problem Description
The user reported that iv set leaking issues that occured at the filter."we are getting numerous complaints that the tpn tubing b2-70071-df-120 lot #16087216 is leaking at the filter.There has been approximately 5 cases where tpn's were being infused and the tubing continued to leak at the filter.No one was injured.".
Additional Manufacturer Narrative
The user-reported leaking issue cannot be confirmed.Zyno medical performed the investigation testing on 10 unused samples from the same lot on 09/08/2017.There was no physical damage found on the samples tested, and no leakage was observed near the filter.The user-reported issue cannot be duplicated.(b)(4).
Event or Problem Description
This is a follow-up for the initially filed mdr (3006575795-2017-00223).

• 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: 6674989
• Report Number: 3006575795-2017-00223
• Device Sequence Number: 13464085
• Product Code: FPA
• UDI-Device Identifier: 00814371020174
• UDI-Public: 00814371020174
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/15/2017

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-120
• Device Lot Number: 16087216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2017
• Supplement Date Received by Manufacturer: 06/19/2017
• Initial Report FDA Received Date: 06/28/2017
• Supplement Report FDA Received Date: 09/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1