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

Model Number	B2-70072
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	05/16/2017
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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 or Problem 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
• Common Device Name: IV ADMINISTRATION SET
• Manufacturer (Section D): ZYNO MEDICAL LLC; 177 pine street; natick MA 01760
• MDR Report Key: 6587646
• Report Number: 3006575795-2017-00130
• Device Sequence Number: 838321
• Product Code: FPA
• UDI-Device Identifier: 00814371020198
• UDI-Public: 00814371020198
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K132841
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: B2-70072
• Device Catalogue Number: B2-70072
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2017
• Supplement Date Received by Manufacturer: 05/16/2017
• Initial Report FDA Received Date: 05/24/2017
• Supplement Report FDA Received Date: 07/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1