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

Model Number	B2-70072
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	Fever (1858)
Date of Event	01/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The service provider provided the investigation report on 02/03/2021.The affected device was returned from the customer.Visual inspection confirmed that there is unknown substance in the drip chamber.The device has no physical damage.An infusion test was performed using the device and no other issue was observed.The device will be returned to the contract manufacturer for further evaluation.
Event or Problem Description
On (b)(6) 2021, a distributor of zyno medical reported a complaint.A user facility representative contacted the distributor on 01/27/2021 and stated that "an administration set model b2-70072 lot 20066195 set was dirty on the inside of the drip chamber".The medication being infused was vidaza.The device operator was a registered nurse.A patient was involved.The patient was not harmed.The user facility representative reported "it was the only set that we know of; when notified of it, all tubing on shelf was inspected, and all was good." "pt had fever yesterday and today.Was tested for covid (to rule that out- was negative).Vidaza day 3 & 4 held.Pt started on augmentin." the user facility representative also stated that "mixer and rn did not notice before (the infusion), only when disposed of, but they can't say with 100% accuracy." on 02/02/2021, the distributor provided additional information.The set did not have any other infusion done with another medication before this infusion.The rn did not see the particles in the drip chamber at the start of the infusion.It was only noticed after the infusion completed.The contract manufacturer of the affected device is becton, dickinson and company.
Additional Manufacturer Narrative
The service provider provided the investigation report on 06/23/2021.The actual device was examined.The foreign particles are embedded degraded plastic material, which is soft pvc from the injection molding process.A batch review was performed on the affected lot.All the planned cleaning's of the plasticization group were done according to the scheduling.No anomalies were recorded.Complaint data was reviewed for one year period for model b2 70072.No additional complaints were found for the same failure mode.Based on the investigation results, no systemic cause was identified for this defect.Corrective actions were implemented to avoid similar cosmetic defects.
Event or Problem Description
This is a follow-up for the initially filed mdr (3006575795-2021-00003).

• Brand Name: ZYNO MEDICAL ADMINISTRATION SET FOR Z-800 INFUSION PUMP SYSTEM
• Common Device Name: IV ADMINISTRATION SET
• MDR Report Key: 11307455
• Report Number: 3006575795-2021-00003
• Device Sequence Number: 19740590
• Product Code: FPA
• UDI-Device Identifier: 00814371020198
• UDI-Public: 00814371020198
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 08/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/12/2023
• Device Model Number: B2-70072
• Device Catalogue Number: B2-70072
• Device Lot Number: 20066195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2021
• Supplement Date Received by Manufacturer: 06/23/2021
• Initial Report FDA Received Date: 02/10/2021
• Supplement Report FDA Received Date: 08/06/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: VIDAZA (AZACITIDINE).