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

Model Number	B2-70071-D
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	08/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer is currently waiting for the arrival of the unused samples from the same lot #.
Event or Problem Description
The user reported experiencing administration set leaking issue."this iv tubing is leaking constantly.It used to only be once in a while, but now it is every single tubing.Even with both clamps secured.The filter tubing is worse, but at least has the additional slide clamp.This is a huge risk for chemo spills.Fluid runs out the end (where it would attach to the patient) even with both clamps secured and air can back up into the lines as well.It has been an issue from the beginning, but has been a daily occurrence for the past 3-4 months." the user did not save the affected set after using for chemotherapy.No patient injury or harm occurred.No event date was provided by the reporter.The user reported set leaking issue due to clamps not working.Two types of administration sets were involved: filtered administration set and administration sets without filter.This report addresses the leaking issue with the (b)(4) administration set (no filter), and mdr 3006575795-2017-00254 address the leaking issue with (b)(4) administration set with (filter).
Additional Manufacturer Narrative
The user-reported leaking issue cannot be confirmed.The customer service representative at zyno medical was notified by the customer on 08/30/2017 that the user no longer had available samples with the same lot number and no device would be sent back to zyno medical for device evaluation.A quality alert was sent to the contract supplier on 08/15/2017 for trending purpose.
Event or Problem Description
This is a follow-up for the initially filed mdr (3006575795-2017-00253).

• 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: 6785795
• Report Number: 3006575795-2017-00253
• Device Sequence Number: 1038360
• Product Code: FPA
• UDI-Device Identifier: 00814371020150
• UDI-Public: 00814371020150
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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-D
• Device Catalogue Number: B2-70071-D
• Device Lot Number: 17015022
• 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: 08/02/2017
• Supplement Date Received by Manufacturer: 08/02/2017
• Initial Report FDA Received Date: 08/10/2017
• 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