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

Model Number A2-80071-DF

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354); Improper Flow or Infusion (2954)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/21/2020

Event Type  malfunction  

Manufacturer Narrative

Zyno medical is waiting for the testing report from the service provider.

Event 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 a2-80071-df lot 18065027 blood was leaking to and out of the small filter." the actual affected device was discarded by the user.A sample set from the same lot number was returned for investigation.The device operator was a registered nurse.No medication was being infused.A patient was involved, but was not harmed or injured.The contract manufacturer of the affected device is becton, dickinson and company.

Event Description

This is a follow-up for the initially filed mdr (3006575795-2020-00009).

Manufacturer Narrative

The service provider provided the evaluation report to zyno medical on 08/31/2020.An unused sample for the same lot of the affected administration set was tested.Visual inspection confirmed that there was no defect or damage to the set.An infusion was completed with no visible leak noticed from the 0.2 micro high-flow filter.The administration set passes the test and meets specifications.The reported issue was not confirmed.

• Brand Name: ZYNO MEDICAL ADMINISTRATION SET FOR Z-800 INFUSION PUMP SYSTEM
• Type of Device: IV ADMINISTRATION SET
• Manufacturer (Section D): ZYNO MEDICAL, LLC; 177 pine street; natick, ma
• MDR Report Key: 10466723
• MDR Text Key: 205113853
• Report Number: 3006575795-2020-00009
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00814371020075
• UDI-Public: 00814371020075
• Combination Product (y/n): N
• PMA/PMN Number: K132841
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 08/31/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2021
• Device Model Number: A2-80071-DF
• Device Catalogue Number: A2-80071-DF
• Device Lot Number: 18065027
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/06/2020
• Initial Date FDA Received: 08/28/2020
• Supplement Dates Manufacturer Received: 08/31/2020
• Supplement Dates FDA Received: 09/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1