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

Model Number	BX70071D
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2020
Type of Reportable Event	Malfunction
Event or Problem Description
On 01/14/2020, a user facility representative reported a complaint that "an administration set model n/a lot # also n/a is leaking right below the drip chamber.This happened three separate times and one of the sets is being discarded." a patient was involved but was not harmed or injured.The device operator was a registered nurse.The medication being infused was saline and iron sucrose.The contract manufacturer of the affected device is (b)(4) medical co.Ltd.This complaint was determined as reportable during a retrospective review performed in (b)(6) 2022.This mdr is being submitted as part of remediation actions.
Additional Manufacturer Narrative
The service provider provided the evaluation report on 01/29/2021.Three used administration sets (bx70071d lot# 1811011) were returned from the customer and tested.Leaking below the drip chamber was observed.The reported issue was confirmed.
Event or Problem Description
This is a follow-up for the initially filed mdr (3006575795-2022-00041).
Additional Manufacturer Narrative
Correction: remove "this complaint was determined as reportable during a retrospective review performed in september 2022.This mdr is being submitted as part of remediation actions." in b5 of the initial mdr report #3006575795-2022-00041.Additional information: mdr report #3006575795-2022-00041 was submitted september 30, 2022, for complaint (b)(4).Mdr report #3006575795-2022-00041 was submitted to document an individual incident of the three (3) submitted under a single mdr report #3006575795-2021-00002, complaint #(b)(4).

• Brand Name: ZYNO MEDICAL ADMINISTRATION SET FOR Z-800 INFUSION PUMP SYSTEM
• Common Device Name: IV ADMINISTRATION SET
• Manufacturer (Section D): ZYNO MEDICAL, LLC; 177 pine street; natick MA 01760
• Manufacturer (Section G): ZYNO MEDICAL, LLC; 177 pine street; natick MA 01760
• Manufacturer Contact: chaoyoung lee ; 177 pine street; natick, MA 01760
• MDR Report Key: 15522115
• Report Number: 3006575795-2022-00041
• Device Sequence Number: 16774302
• Product Code: FPA
• UDI-Device Identifier: 00814371020532
• UDI-Public: 00814371020532
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K132841
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2022

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: 12/14/2021
• Device Model Number: BX70071D
• Device Catalogue Number: BX-70071-D
• Device Lot Number: 1811011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2021
• Supplement Date Received by Manufacturer: 01/18/2021
• Initial Report FDA Received Date: 09/30/2022
• Supplement Report FDA Received Date: 11/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown