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

Model Number	B2-70071-P
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	05/10/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zyno medical has received the investigation report from the contract supplier on (b)(6) 2017.The free-flowing issue with the pinch clamp closed was confirmed as an isolated event, which may be due to the dislocation of the pinch clamp.The details can be found in the attached report.Upon receiving the complaint, it was initially determined as not reportable by the manufacturer by following the company procedures.This mdr is filed retrospectively filed according to the current internal mdr decision guidance at zyno medical.The mdr decision was made on (b)(6) 2017.(b)(4).
Event or Problem Description
The user reported to a zyno medical sales territory manager on (b)(6) 2016 that they experienced an administration set issue: "i just experienced and incident with the primary pump tubing (with upper y-port) when doing a demo for some staff.The tubing came out with the "pinch" clamp, clamped, however the fluid was flowing.I check to be sure the tubing was actually caught and it was.I then slid the clamp to another section of tubing and again it just flowed." no patient injury or harm occured for this case.

• 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: 6890042
• Report Number: 3006575795-2017-00274
• Device Sequence Number: 10950439
• Product Code: FPA
• UDI-Device Identifier: 00814371020181
• UDI-Public: 00814371020181
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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
• Report Date (Section B): 09/25/2017

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: B2-70071-P
• Device Catalogue Number: B2-70071-P
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2016
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2016
• Initial Report FDA Received Date: 09/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1