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

Model Number B2-70072

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Not Applicable (3189)

Event Date 05/16/2017

Event Type  malfunction  

Manufacturer Narrative

The affected iv set is being sent to the contract supplier for investigation.Zyno medical has sent a quality alert to the contract supplier on 05/19/2017.

Event Description

The user reported an iv set leaking issue.A hole was created in the tubing when the pinch clamp was released."the iv set that the nurses were testing on (demonstration) in which she tried to disengage the pinch clamp and released it, but during the release of the pinch clamp it caused a small hole in the tubing." no patient was involved in this case.

Manufacturer Narrative

The user reported issue was confirmed.Zyno medical has received the testing report from the contract supplier on 07/17/2017.The root cause of the hole of the tubing was identified as equipment damage.The acrylic guard, which covered the calibrated ruler that used to cut the tubing, had a crack and could potentially cause damage in the tubing.Details of the testing results can be found in the attached report.

Event Description

This is a follow-up for the initially filed mdr (3006575795-2017-00130).

• 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: 6587646
• MDR Text Key: 75857970
• Report Number: 3006575795-2017-00130
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00814371020198
• UDI-Public: 00814371020198
• 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: 07/18/2017

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 Model Number: B2-70072
• Device Catalogue Number: B2-70072
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/16/2017
• Initial Date FDA Received: 05/24/2017
• Supplement Dates Manufacturer Received: 05/16/2017
• Supplement Dates FDA Received: 07/19/2017
• 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