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

Model Number B2-70071-DF

Device Problem Fluid Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/17/2022

Event Type  malfunction  

Manufacturer Narrative

Zyno medical is waiting for the arrival of the affected device.

Event Description

On (b)(6) 2022, zyno medical received a complaint from an end user regarding a leaking issue. It was reported that "the leak was coming from below the bottom filter on the tubing, and it would happen immediately. " the end user also stated that "this event took place 4 times in a single day all on (b)(6) 2022". The device operator was a nurse. Medication being infused was remicade. There was a patient involved. The patient was not harmed or injured. The contract manufacturer of the affected device is becton, dickinson and company.

• 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 01760
• Manufacturer (Section G): ZYNO MEDICAL, LLC; 177 pine street; natick MA 01760
• Manufacturer Contact: chaoyoung lee ; 177 pine street; natick, MA 01760
• MDR Report Key: 14014031
• MDR Text Key: 289278780
• Report Number: 3006575795-2022-00008
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132841
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional

Reporter Occupation

• Type of Report: Initial
• Report Date: 03/31/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: B2-70071-DF
• Device Catalogue Number: B2-70071-DF
• Device Lot Number: 21065899
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial