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

Model Number	B2-70071-DF
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On 04/20/2021, the distributor confirmed the actual affected set won't be returned for evaluation.On 05/03/2021, zyno medical received unused sample sets of the same lot returned from the customer.Investigation will be performed using the sample sets.
Event or Problem Description
On 6.23 on 04/20/2021, a distributor of zyno medical reported a complaint.A user facility representative contacted the distributor on 04/20/2021 and stated that "an administration set model b2-70071-df lot 21015465.Set had loose pieces of the spike on the side of it once it was spiked into the bag." a patient was involved but was not harmed or injured.The device operator was a registered nurse.The medication being infused was unknown.The contract manufacturer of the affected device is (b)(4).
Additional Manufacturer Narrative
The service provider provided the investigation report on 05/14/2021.The actual device was inspected visually.No damage or loose pieces were noticed.The device was tested by running an infusion with water.After the infusion, the set was inspected again, and no defects were observed.The reported issue could not be confirmed.
Event or Problem Description
This is a follow-up for the initially filed mdr (3006575795-2021-00025).
Additional Manufacturer Narrative
The contract manufacturer provided the investigation report on 07/27/2021.A trend review was performed for b2-70071-df.No qns or no additional complaints related to this failure mode were found in a 12-month period.Two unused samples from the same lot# were returned from the customer.The samples were inspected and tested.No loose material or particles were observed in both samples.The root cause could not be established.
Event or Problem Description
This is a second follow-up for the initially filed mdr (3006575795-2021-00025).

• Brand Name: ZYNO MEDICAL ADMINISTRATION SET FOR Z-800 INFUSION PUMP SYSTEM
• Common Device Name: IV ADMINISTRATION SET
• MDR Report Key: 11776834
• Report Number: 3006575795-2021-00025
• Device Sequence Number: 17143345
• Product Code: FPA
• UDI-Device Identifier: 00814371020167
• UDI-Public: 00814371020167
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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,Followup
• Report Date (Section B): 08/13/2021

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: 01/06/2024
• Device Model Number: B2-70071-DF
• Device Catalogue Number: B2-70071-DF
• Device Lot Number: 21015465
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2021
• Supplement Date Received by Manufacturer: 05/14/2021; 07/27/2021
• Initial Report FDA Received Date: 05/05/2021
• Supplement Report FDA Received Date: 06/02/2021; 08/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2021
• 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