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

Model Number	B2-70071-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	04/22/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A) the user-reported leakage issue was confirmed.A supplier corrective action request ((b)(4)) had been issued to address this issue.Root case was identified by the supplier that, during the bonding process of drip chamber to their components yielded an anomaly of "white fog".Operators did not identify this as a potential problem and proceeded to process entire lot with this anomaly.After the bonding process a leakage test performed and no leaks detected at that time.Mainly it is described as uneven adhesive coverage causing " white fog".Corrective action and preventive action (capa#(b)(4)) was taken by the supplier (xingda) to address this issue.B) 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 08/11/2016.C) zyno medical submitted an e-mdr (3006575795-2016-00140_complaint (b)(4)) on 10/27/2016 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 leaking at the drip chamber of the iv set.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: 6247665
• Report Number: 3006575795-2016-00140
• Device Sequence Number: 13679652
• Product Code: FPA
• UDI-Device Identifier: 00814371020150
• UDI-Public: 00814371020150
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 01/12/2017

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: 04/01/2017
• Device Model Number: B2-70071-D
• Device Lot Number: 1404011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2015
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2015
• 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