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

Model Number AA-80075

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/01/2018

Event Type  malfunction  

Manufacturer Narrative

The affected set is to be evaluated by the service provider.

Event Description

A distributor reported a leaking issue of an administration set to zyno medical on (b)(4) 2018.The distributor received an email on (b)(4) 2018, stating that "upon starting emend, fluid noted to be dripping from iv tubing vent.Closed vent and infusion completed with no further issues." no patient injury was reported in this case.(b)(4).

Event Description

This is a follow-up for the initially filed mdr (3006575795-2018-00070).

Manufacturer Narrative

The reported leaking issue could not be confirmed.On 04/15/2019, zyno medical was informed by the service provider that the affected administration set had been lost.The administration set was noted as having arrived on 12/10/2018 by an employee who is no longer working with this service provider.The current employee of the service provider conducted a thorough search of the premises but did not locate the affected device.

• Brand Name: ZYNO MEDICAL ADMINISTRATION SET FOR Z-800 INFUSION PUMP
• Type of Device: IV ADMINISTRATION SET
• Manufacturer (Section D): ZYNO MEDICAL LLC; 177 pine street; natick MA 01760
• MDR Report Key: 8194300
• MDR Text Key: 131342363
• Report Number: 3006575795-2018-00070
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00814371020600
• UDI-Public: 00814371020600
• Combination Product (y/n): N
• PMA/PMN Number: K120685
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 12/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AA-80075
• Device Catalogue Number: AA-80075
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1