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

Model Number	BX-70071-D
Medical Device Problem Codes	Fluid/Blood Leak (1250); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The service provider received the actual affected administration set, and 20 unused sample sets from the customer on 11/09/2020.Currently, zyno medical is waiting for the evaluation results from the service provider.
Event or Problem Description
On 10/29/2020, a distributor of zyno medical reported a complaint.A user facility representative contacted the distributor on 10/28/2020, and stated that "an administration set model bx-70071-d lot 1811011 is leaking right below the drip chamber.This is not the first time this has happened.I would estimate this had occurred over 10 times in the last six months." a patient was involved but was not harmed or injured.The device operator was a registered nurse.Medication being infused was unknown.No information was provided for the event date.The contract manufacturer of the affected device is podo xingda (tianjin) medical co., ltd.
Event or Problem Description
This is a follow-up for the initially filed mdr (3006575795-2020-00036).
Additional Manufacturer Narrative
The service provider tested the actual affected device on 11/13/2020.Leaking was observed below the drip chamber.The reported issue was confirmed.The service provider also tested 20 pieces of unused samples from the same lot number on 11/20/2020.The unused samples were returned from the customer.Visual inspection didn't find any damage that would cause any leak.No leakage was detected during the infusion test.The reported issue couldn't be repeated with unused samples.On 11/27/2020, a quality alert was sent to the contract manufactuer to notify them about the complaint.

• 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
• MDR Report Key: 10856033
• Report Number: 3006575795-2020-00036
• Device Sequence Number: 3210784
• 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: distributor,health profession
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2020

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: BX-70071-D
• Device Catalogue Number: BX-70071-D
• Device Lot Number: 1811011
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2020
• Supplement Date Received by Manufacturer: 11/13/2020
• Initial Report FDA Received Date: 11/17/2020
• Supplement Report FDA Received Date: 12/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1