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

Model Number	A2-80072-F
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/08/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A) the returned iv sets have been sent to the contract supplier for investigation on 09/09/2016.The manufacturer is still waiting for the results.B) the initial determination by following the company procedures was that this complaint did not constitute an mdr reportable event.This mdr is filed retrospectively as a corrective action to address one of the fda inspection observation made on 08/11/2016.C) zyno medical submitted an e-mdr (3006575795-2016-00013_complaint 2016v-028) on 08/23/2016 through the fda's website and received the receipt.But due to some technical difficulties and confusion, the file didn't pass with all three acknowledgements.This is a re-submission regarding the same event.
Event or Problem Description
The user reported " we had a filter tubing leak resulting in the infusion backing up and losing sterility.Luckily it was caught in time and there was no adverse on the patient or staff.The medication however was a loss.".
Additional Manufacturer Narrative
The user-reported issue was confirmed.The contract supplier provided the investigation findings to zyno medical on 03/10/2017.A detailed evaluation report from the contract supplier is attached.Affected iv sets are under recall #74892.
Event or Problem Description
This is a follow-up for the initially filed mdr (3006575795-2016-00013).

• 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: 6230398
• Report Number: 3006575795-2016-00013
• Device Sequence Number: 673895
• Product Code: FPA
• UDI-Device Identifier: 00814371020129
• UDI-Public: 00814371020129
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2017

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 Expiration Date: 09/01/2018
• Device Model Number: A2-80072-F
• Device Lot Number: 15096765
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/06/2017
• Supplement Report FDA Received Date: 03/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1