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

Model Number	BX70070
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	12/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zyno medical is waiting for the arrival of the affected device.
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 bx-70070, lot number 1904010 had a leak." a patient was involved, but there was no harm.The device operator was a registered nurse.The medication being infused was ertapenem.The distributor asked the user facility representative to provide further information on where the leaking came from but the user facility reprensentative could not specify any more information.The contract manufacturer of the affected device is podo xingda (tianjin) medical co., ltd.
Additional Manufacturer Narrative
Zyno medical sent a quality alert to the contract manufacturer on 03/18/2020.The contract manufacturer provided the investigation report on 05/14/2020.Possible root causes can be: 1) poor adhesion between the tubing and the luer lock connector; 2) deformation of luer lock connector.6 pieces of retained samples from the same lot number were inspected for adhesive bonding and tubing dimension.No issue was identified and the samples meet specifications.Investigation and analysis indicate that the complaint should be an individual case.
Event or Problem Description
This is the second follow-up for the initially filed mdr 3006575795-2020-00001.
Additional Manufacturer Narrative
Zyno medical llc received the administration set evaluation report from the service provider on 03/06/2020.The actual device was tested.Leaking was observed between the tubing and the luer lock on the administration set.The reported issue was confirmed.Possible root cause could be insufficient glue between the tubing and the luer lock.
Event or Problem Description
This is a follow-up for the initially filed mdr (3006575795-2020-00001).

• 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 01760
• MDR Report Key: 9597074
• Report Number: 3006575795-2020-00001
• Device Sequence Number: 19457751
• Product Code: FPA
• UDI-Device Identifier: 00814371020525
• UDI-Public: 00814371020525
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,Followup
• Report Date (Section B): 05/14/2020

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: 05/09/2022
• Device Model Number: BX70070
• Device Catalogue Number: BX-70070
• Device Lot Number: 1904010
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2020
• Supplement Date Received by Manufacturer: 03/06/2020; 05/14/2020
• Initial Report FDA Received Date: 01/16/2020
• Supplement Report FDA Received Date: 03/23/2020; 05/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1