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

Model Number	B2-70072-F
Medical Device Problem Codes	Fluid/Blood Leak (1250); Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer has discarded the affected sets.No investigation can be performed.No results/conclusion is available.The complaint couldn't be confirmed.
Event or Problem Description
On 03/12/2020, a distributor of zyno medical reported a complaint.A user facility representative contacted the distributor stating that "an administration set model b2-70072-f lot number 19066630 was leaking from the filter." a patient was involved but not harmed.The device operator was a registered nurse.The medication being infused was keytruda.The contract manufacturer of the affected device is becton, dickinson and company.
Additional Manufacturer Narrative
Correction: two used sets were returned from the user to the distributor on (b)(6) 2020.The distributor sent the sets to the contract manufacturer for evaluation on (b)(6) /2020.Zyno medical is currently waiting for the evaluation results from the contract manufacturer.
Event or Problem Description
This is a follow-up for the initially filed mdr 3006575795-2020-00003.The associated zyno medical complaint number is (b)(4).On 04/06/2020, zyno medical received a letter from fda, which provides additional information regarding complaint (b)(4).The letter is to notify zyno medical regarding a report (mw5093332) in fda's medwatch program.The user reported the filter-leaking issue to fda on (b)(6) 2020 stating that " zyno medical administration set b2-70072-f filters have leaked chemotherapy from the filter 4 times in 2 week period at our practice leading to chemo spillage and product wastage".Zyno medical has already filed an initial mdr for this event on (b)(6) 2020.This follow-up report is to include the additional information provided by the fda letter and provide corrected data.
Additional Manufacturer Narrative
The contract manufacturer provided the investigation report on 07/07/2020.Trend review was performed for complaints and raw material.One complaint and one quality notice related to the reported failure were identified in a 1-year period.The actual device was tested and the leakage was observed.The reported issue was confirmed.Possible root cause can be the booster, which controlled the amplitude of the welder, was not operating adequately.This potentially lead to inadequate welding on the defective part.Quality alert was generated for qa and operator's awareness about this failure.Corrective actions had been completed to address the issue.
Event or Problem Description
This is the second mdr follow up for the initially filed mdr.

• 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: 9871128
• Report Number: 3006575795-2020-00003
• Device Sequence Number: 526439
• Product Code: FPA
• UDI-Device Identifier: 00814371020204
• UDI-Public: 00814371020204
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K132841
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 07/07/2020

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: 06/21/2022
• Device Model Number: B2-70072-F
• Device Catalogue Number: B2-70072-F
• Device Lot Number: 19066630
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2020
• Supplement Date Received by Manufacturer: 04/06/2020; 07/07/2020
• Initial Report FDA Received Date: 03/24/2020
• Supplement Report FDA Received Date: 04/16/2020; 07/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1