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	05/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The distributor has received unused samples returned from the customer on may 21, 2020.Samples will be sent to the contract manufacturer for evaluation and investigation.
Event or Problem Description
On (b)(6) 2020, a distributor of zyno medical reported a complaint.A user facility representative contacted the distributor stating that "an administration set model b2-70072-f lot 19126200 was leaking where the filter is attached to the tubing." a patient was involved, but was not harmed or injured.The device operator was a registered nurse.The medication being infused was ceftriaxone.The contract manufacturer of the affected device is becton, dickinson and company.
Event or Problem Description
This is a follow-up for the initially filed mdr (3006575795-2020-00004).
Additional Manufacturer Narrative
Zyno medical sent a quality alert to the contract manufacturer on 05/27/2020.The contract manufacturer received the unused sets on 06/23/2020.The contract manufacturer provided the investigation report on 07/17/2020.The dhr review found no deviations.Trend review was performed for complaints and raw material.Two complaints and one quality notice related to the reported failure were identified in a 1-year period.Unused samples returned from the customer were tested and the leakage could not be replicated.The root cause couldn't be identified.The complaint couldn't be confirmed.

• 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: 10084462
• Report Number: 3006575795-2020-00004
• Device Sequence Number: 677850
• 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): 07/17/2020

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: 12/27/2022
• Device Model Number: B2-70072-F
• Device Catalogue Number: B2-70072-F
• Device Lot Number: 19126200
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2020
• Supplement Date Received by Manufacturer: 07/17/2020
• Initial Report FDA Received Date: 05/22/2020
• Supplement Report FDA Received Date: 07/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1