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

Model Number B2-70071-P

Device Problems Fluid/Blood Leak (1250); Device Operates Differently Than Expected (2913)

Patient Problem Not Applicable (3189)

Event Date 03/10/2017

Event Type  malfunction  

Manufacturer Narrative

The failed iv sets have been sent to the contract supplier for evaluation on 03/17/2017.The manufacturer is still waiting for the results.

Event Description

The user reported that leakage of an iv set occurred past the roller clamp."this time i had tested pumps and the tube left hanging, the bag only had about 375ml remaining-which all leaked out past the 2 closed clamps".No patient was involved in this case.

Manufacturer Narrative

Zyno medical has received the investigation report from the contract manufacturer on 04/25/2017.The user-reported complaint was confirmed.The root cause was unknown and was found to not be related to the manufacturing process.

Event Description

This is a follow-up for the initially filed mdr (3006575795- 2017-00075).

• 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: 6432746
• MDR Text Key: 70906398
• Report Number: 3006575795-2017-00075
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00814371020181
• UDI-Public: 00814371020181
• 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: 04/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B2-70071-P
• Device Lot Number: 16105861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2016
• 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