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

Model Number	B2-70072-F
Medical Device Problem Codes	Fluid/Blood Leak (1250); Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zyno medical is waiting for the arrival of the affected device.
Event or Problem Description
On 2/18/2020, a distributor of zyno medical reported a complaint.A user facility representative contacted the distributor stating that "it has been brought to my attention that there was a leak from the filter of an administration set that caused a significant spill of one of our research drugs on (b)(6) 2020.We are currently using b2-70072-f tubing for our filtered tubing.Lot number (10) 19116557.Expiration date (17) 2022-11-16.We do still have the tubing for this instance." a patient was involved, but was not harmed or injured.The device operator was a registered nurse.The contract manufacturer of the affected device is becton, dickinson and company.
Additional Manufacturer Narrative
Zyno medical sent a quality alert to the contract manufacturer on 02/26/2020.Customer returned administration set was sent to the contract manufacturer on 03/10/2020.The contract manufacturer provided the investigation report on 07/15/2020.Trend review was performed for complaints and raw material.One complaint and one quality notice related to the reported failure were identified in a 1-year period.The actual device was tested and the leakage was observed.The reported issue was confirmed.Possible root cause can be the booster, which controlled the amplitude of the welder, was not operating adequately.This potentially lead to inadequate welding on the defective part.Quality alert was generated for qa and operator's awareness about this failure.Corrective actions had been completed to address the issue.
Event or Problem Description
This is a follow-up for the initially filed mdr (3006575795-2020-00002).

• Brand Name: ZYNO MEDICAL ADMINISTRATION SET FOR Z-800 INFUSION PUMP SYSTEM
• Common Device Name: IV ADMINISTRATION SET
• Manufacturer (Section D): ZYNO MEDICAL, LLC; 177 pine street; natick, ma
• MDR Report Key: 9765729
• Report Number: 3006575795-2020-00002
• Device Sequence Number: 13579224
• Product Code: FPA
• UDI-Device Identifier: 00814371020204
• UDI-Public: 00814371020204
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K132841
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2020

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 Expiration Date: 11/16/2022
• Device Model Number: B2-70072-F
• Device Catalogue Number: B2-70072-F
• Device Lot Number: 19116557
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2020
• Supplement Date Received by Manufacturer: 07/15/2020
• Initial Report FDA Received Date: 02/27/2020
• Supplement Report FDA Received Date: 07/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1