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 Codes	Fluid/Blood Leak (1250); Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zyno medical is waiting for the arrival of the device.
Event or Problem Description
A distributor reported a leaking issue of an administration set to zyno medical on (b)(6) 2018.The distributor received a call from the initial reporter, stating that the administration set tubing was leaking below the drip chamber.The affected administration set was infusing saline.There was no patient injury and no patient information was provided to zyno medical.The contract supplier of the affected device is podo xingda (tianjin) medical co.Ltd.
Additional Manufacturer Narrative
The reported leaking issue was confirmed.The administration set was evaluated on (b)(6) 2018 and was found to be leaking below the drip chamber.Zyno medical issued the scar (b)(6) 2018 to the contract (b)(4) on (b)(6) 2018 for the administration set dirp chamber leaking issue in three lots, including lot #1606009.The contract manufacturer stated that they had identified the root cause as improper welding process around the d8 air-screened membrane and implemented the corrective and preventive actions from lot #1702003.All the actions of scar 2018-001 have been completed and accepted on (b)(6) 2018.This scar is now waiting for effectiveness check.
Event or Problem Description
This is a follow-up for the initially filed mdr (3006575795-2018-00062).

• 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: 7918806
• Report Number: 3006575795-2018-00062
• Device Sequence Number: 19281923
• Product Code: FPA
• UDI-Device Identifier: 00814371020150
• UDI-Public: 00814371020150
• 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: distributor,health profession
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2018

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: 08/01/2019
• Device Model Number: B2-70071-D
• Device Catalogue Number: B2-70071-D
• Device Lot Number: 1606009
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2018
• Supplement Date Received by Manufacturer: 10/23/2018
• Initial Report FDA Received Date: 09/28/2018
• Supplement Report FDA Received Date: 10/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1