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 Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zyno medical has issued a scar (scar 2020-003) to the contract manufacturer regarding the complaint.Used samples returned from the customer couldn't be sent to the contract manufacturer due to the custom control in (b)(6).The samples will be tested by the service provider.Currently, zyno medical is waiting for the investigation results.
Event or Problem Description
On (b)(6) 2020, a distributor of zyno medical reported a complaint.A user facility representative contacted the distributor on (b)(6) 2020 stating that "an administration set model bx-70071-d lot 1709004 had a dirty spike." no patient was involved.No medication was used.The device operator was a nurse practitioner.The contract manufacturer of the affected device is podo xingda (tianjin) medical co.Ltd.
Additional Manufacturer Narrative
The service provider performed visual inspection of the defective administration set sample.The reported issue was confirmed.
Event or Problem Description
This is a follow-up for the initially filed mdr (3006575795-2020-00007).
Additional Manufacturer Narrative
The contract manufacturer provided the updated investigation report on 09/03/2020.The contract manufacturer have the following inspections in their current procedure: 1.Inspection in the molding process.2.Inspection during the welding of spike air inlet membrane in the assembly process.3.Light inspection of the drip chamber assembly.The contract manufacturer notified their employees about the issue of the complaint and had refresher training of the procedure on 07/22/2020.
Event or Problem Description
This is the third mdr follow up for the initially filed mdr (3006575795-2020-00007).
Event or Problem Description
This is the second mdr follow up for the initially filed mdr.
Additional Manufacturer Narrative
The contract manufacturer provided the investigation report on (b)(6) 2020.The possible root cause has been identified as "the spike contacts the lubricant of the injection".Corrective actions taken by the contract manufacturer include: inspection in the molding process inspection during the welding of spike air inlet membrane in the assembly process light inspection of the drip chamber assembly.

• 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
• MDR Report Key: 10209695
• Report Number: 3006575795-2020-00007
• Device Sequence Number: 3270592
• Product Code: FPA
• UDI-Device Identifier: 00814371020532
• UDI-Public: 00814371020532
• Combination Product (Y/N): N
• 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): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/03/2020

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: 03/06/2021
• Device Model Number: BX-70071-D
• Device Catalogue Number: BX-70071-D
• Device Lot Number: 1709004
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2020
• Supplement Date Received by Manufacturer: 07/10/2020; 08/07/2020; 09/03/2020
• Initial Report FDA Received Date: 06/29/2020
• Supplement Report FDA Received Date: 07/24/2020; 08/28/2020; 09/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1