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 Codes	Contamination (1120); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer is in the process of sending the affected device to the contract supplier for evaluation on 12/06/2017.A quality alert is issued to the contract supplier on 12/06/2017.
Event or Problem Description
The user reported a foreign object issue of the device on (b)(6) 2017."we had an incident today involving an administration set that contained a contaminant.This was a primary tubing set (b2-70072) that was used and several medications were y-sited into it before the contaminant was noticed.We have kept the tubing and have included a picture.It appears to be wedged between the tubing/port connection." no patient injury occurred for this case.The medications used during this infusion were sodium chloride, rituximab, vincristine, doxorubicin, emend, aloxi, and benadryl.The event date was reported as (b)(6) 2017.
Additional Manufacturer Narrative
The user-reported foreign object issue was confirmed.Zyno medical has received the investigation report from the contract supplier carefusion on (b)(6) 2017.The contract supplier examined the affected device and confirmed the presence of the contaminant.Through the review of the manufacturing procedure and assembly process, the contract supplier determined that the issue could not have been generated during the manufacturing process.It is possible that the contaminant was accidentally introduced into the tubing during device use.The root cause of the issue was unknown.Further details can be found in the attached investigation report.
Event or Problem Description
This is a follow-up for the initially filed mdr (3006575795-2017-00329).

• 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: 7097072
• Report Number: 3006575795-2017-00329
• Device Sequence Number: 19316109
• Product Code: FPA
• UDI-Device Identifier: 00814371020198
• UDI-Public: 00814371020198
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2017

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: 17035270
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2017
• Supplement Date Received by Manufacturer: 01/08/2018
• Initial Report FDA Received Date: 12/07/2017
• Supplement Report FDA Received Date: 01/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1