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

Model Number A2-80071-DF120

Device Problem Material Integrity Problem (2978)

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

Event Date 03/21/2017

Event Type  malfunction  

Manufacturer Narrative

The manufacturer is still waiting for the arrival of the iv sets.

Event Description

The user reported a tubing seperation issue of the iv set during infusion.The tubing disconnected from the filter house.No patient harm or injury was involved in this case.

Manufacturer Narrative

The user reported issue was not duplicated using the unused samples from the same lot number.The failed iv set was not captured by the user, but samples from the same lot number were sent back to zyno medical for evaluation.The test result was available on 04/13/2017.

Event Description

This is a follow-up for the initially filed mdr (3006575795-2017-00090).

• 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
• Manufacturer (Section G): ZYNO MEDICAL, LLC; 177 pine street; natick MA 01760
• Manufacturer Contact: chaoyoung lee ; 177 pine street; natick, MA 01760 ; 5086502008
• MDR Report Key: 6472422
• MDR Text Key: 72186972
• Report Number: 3006575795-2017-00090
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00814371020082
• UDI-Public: 00814371020082
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A2-80071-DF120
• Device Lot Number: 16037122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1