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

Model Number	BX70071D
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The service provider received samples returned from the customer on (b)(6) 2020.Currently, zyno medical is waiting for the investigation results from the service provider.
Event or Problem Description
On 11/20/2020, a distributor of zyno medical reported a complaint.A user facility representative contacted the distributor on (b)(6) 2020 and stated that an administration set model bx-70071-d lot 1811011 is leaking right below the drip chamber.They had also stated it had happened 10 times over the last six months but did not report it.This is the second complaint from this customer of this type.The other complaint is reported under mdr 3006575795-2020-00036.Complaint (b)(4).A patient was involved but was not harmed or injured.The device operator was a registered nurse.The medication being infused was unknown.The contract manufacturer of the affected device is podo xingda (tianjin) medical co., ltd.
Event or Problem Description
This is a follow-up for the initially filed mdr (3006575795-2020-00039).
Additional Manufacturer Narrative
The service provider provided the evaluation report to zyno medical on 12/18/2020.One used administration set that was involved in the incident and ten unused samples from the same lot of the affected set were tested.Visual inspection confirmed that there was no damage to the sets that would cause any leak to either the used set or the unused samples.The used set had no physical signs of a leak.When the set was set up for an infusion, it would not prime manually or with the pump.The infusion test could not be performed using the used set.The ten unused samples completed the infusion test, and no leak was observed below the drip chamber or anywhere else on the set.The reported issue was not 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 01760
• MDR Report Key: 10953598
• Report Number: 3006575795-2020-00039
• Device Sequence Number: 17016542
• Product Code: FPA
• UDI-Device Identifier: 00814371020532
• UDI-Public: 00814371020532
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K132841
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/31/2020

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: 12/14/2021
• Device Model Number: BX70071D
• Device Catalogue Number: BX-70071-D
• Device Lot Number: 1811011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2020
• Supplement Date Received by Manufacturer: 12/18/2020
• Initial Report FDA Received Date: 12/05/2020
• Supplement Report FDA Received Date: 01/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1