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

Model Number	A2-80071-D
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/27/2013
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The user-reported issue was confirmed.The tubing leaked at the air vent.A supplier corrective action request (scar-007) had been issued to address this issue.The complaint was determined as not mdr reportable at the initial determination by following company procedures.This mdr is retrospectively filed as a corrective action to address one of the fda inspection observations made on (b)(4) 2016.Zyno medical submitted an e-mdr (3006575795-2016-00119_complaint (b)(4)) on 10/26/2016 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 customer reported an issue of the iv set."leaking from the chamber and creating a vacuum that collapsed the chamber and was pulling blood out of the patient into the catheter".No patient injury or harm was involved in 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: 6247843
• Report Number: 3006575795-2016-00119
• Device Sequence Number: 393449
• Product Code: FPA
• UDI-Device Identifier: 00814371020068
• UDI-Public: 00814371020068
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 01/13/2017

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: 02/01/2015
• Device Model Number: A2-80071-D
• Device Lot Number: 1202001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2013
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2013
• Initial Report FDA Received Date: 01/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1