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

Model Number	B2-70071-DF120
Medical Device Problem Codes	Leak/Splash (1354); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	08/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer is waiting for the arrival of 1 affected administration set.Zyno medical has sent a quality alert to its contract supplier on 09/01/2017 regarding this complaint.
Event or Problem Description
The customer reported a leaking issue with administration sets."it is leaking out of the connection at the filter component in about five sets." the customer also reported over the phone that the issue had been happening in the past, but the most recent case was on (b)(6) 2017 while they were priming the tubing.The iv set was leaking below the filter in which it connected with the tubing itself.The customer reported that there was no patient involvement for this case.
Additional Manufacturer Narrative
The user-reported issue could not be confirmed.On (b)(6) 2017, the customer reported to a zyno medical customer service representative that the administration sets were no longer available to be sent back to the manufacturer for evaluation, as they were disposed of by the cleaning crew.Thus, zyno medical could not confirm the complaint.
Event or Problem Description
This is a follow-up for the initially filed mdr (3006575795-2017-00267).

• 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: 6857575
• Report Number: 3006575795-2017-00267
• Device Sequence Number: 13612168
• Product Code: FPA
• UDI-Device Identifier: 00814371020174
• UDI-Public: 00814371020174
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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: B2-70071-DF120
• Device Catalogue Number: B2-70071-DF120
• Device Lot Number: 15115696
• 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: 08/30/2017
• Supplement Date Received by Manufacturer: 10/10/2017
• Initial Report FDA Received Date: 09/12/2017
• Supplement Report FDA Received Date: 10/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1