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

Model Number B2-70072

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem Fever (1858)

Event Date 01/26/2021

Event Type  malfunction  

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 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.

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 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
• Type of Device: IV ADMINISTRATION SET
• MDR Report Key: 11307455
• MDR Text Key: 243811358
• Report Number: 3006575795-2021-00003
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00814371020198
• UDI-Public: 00814371020198
• Combination Product (y/n): N
• PMA/PMN Number: K132841
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 08/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 06/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: VIDAZA (AZACITIDINE).