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

Model Number	A2-80070
Medical Device Problem Codes	Fluid/Blood Leak (1250); Leak/Splash (1354); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zyno medical is waiting for the arrival of the affected device.
Event or Problem Description
Zyno medical was notified of a leaking issue on (b)(6) 2018 from the distributor.The user's description of the incident was forwarded to zyno medical and is as follows: "carboplatin tubing began to leak.Upon further investigation, the tubing appeared to be sliced or cut.Chemo wasted to the floor and two small dots landed on the patient's hand and forearm.The areas on the patient were cleaned with warm water and soap.The floor was cleaned using bleach wipes.The entire bag of carboplatin and tubing was replaced by pharmacy".The drug being infused was carboplatin.There was a delay in delivery due to the incident and chemo was spilled on the floor.No patient injury or harm occurred for this case.The date of the event is (b)(6) 2018.The lot number reported was "16035518 or 17106197".The contract manufacture of the affected set is becton, dickinson and company.
Additional Manufacturer Narrative
The customer stated on (b)(6) 2018 that the affected device was not saved.No evaluation was conducted as the device was not sent in for evaluation.The reported leaking issue was not confirmed.
Event or Problem Description
This is a follow-up for the initially filed mdr (3006575795-2018-00048).
Event or Problem Description
This is a second follow-up for the initially filed mdr (3006575795-2018-00048).
Additional Manufacturer Narrative
The reported issue of sliced tubing was not confirmed.The complaint was reported to the contract manufacturer becton, dickinson and company on 10/25/2018.On 03/15/2019, zyno medical received the evaluation report from the contract manufacturer: "samples were not provided for evaluation.Therefore, it was not possible to confirm the reported condition and identify a possible root cause.A complaint search for the past year (from (b)(6) 2017 to (b)(6) 2018) was conducted and no additional complaints related to the reported condition were identified for model a2-80070.No trend related to this condition was identified.In addition, samples were not available for evaluation to confirm the reported condition or to determine a possible root cause.Therefore, the root cause was deemed as unknown.".

• Brand Name: ZYNO MEDICAL ADMINISTRATION SET FOR Z-800 INFUSION PUMP
• Common Device Name: IV ADMINISTRATION SET
• Manufacturer (Section D): ZYNO MEDICAL, LLC; 177 pine street; natick MA 01760
• MDR Report Key: 7562523
• Report Number: 3006575795-2018-00048
• Device Sequence Number: 1556105
• Product Code: FPA
• UDI-Device Identifier: 00814371020051
• UDI-Public: 00814371020051
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/25/2018

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 Model Number: A2-80070
• Device Catalogue Number: A2-80070
• Device Lot Number: 16035518 OR 17106197
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2018
• Supplement Date Received by Manufacturer: 07/03/2018; 03/15/2019
• Initial Report FDA Received Date: 06/01/2018
• Supplement Report FDA Received Date: 07/11/2018; 04/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1