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

Model Number	BX-70070
Medical Device Problem Codes	Leak/Splash (1354); Mechanical Problem (1384); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is being sent to the contract supplier for evaluation and pending for testing.
Event or Problem Description
Zyno medical was notified of an administration set leaking issue on 04/10/2018 from a distributor: "my customer oncology consultants is having a leaking issue again with their tubing set bx-70070 except this time it is leaking at the top of the drip chamber.I am going to send you the set for further investigation, and just an fyi this tubing set did not have chemo in it just saline".During the follow-up with the distributor representative, it was confirmed that the patient was connected to the infusion pump when issue was noticed, and no injuries were reported.The distributor also confirmed that "pump had been running for about 30 minutes when tubing leak was noticed.The leaking happened at the top of the drip chamber near the bag spike".The lot number of the affected set is 1606009.
Additional Manufacturer Narrative
The reported leaking issue could not be confirmed.The evaluation was completed by an external laboratory on (b)(6) 2018.Details of the test result can be found in the report attached.
Event or Problem Description
This is a follow up report for the initially submitted mdr.

• 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: 7441179
• Report Number: 3006575795-2018-00037
• Device Sequence Number: 13726180
• Product Code: FPA
• UDI-Device Identifier: 00814371020525
• UDI-Public: 00814371020525
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2018

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: Nurse
• Device Expiration Date: 08/01/2019
• Device Model Number: BX-70070
• Device Lot Number: 1606009
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2018
• Supplement Date Received by Manufacturer: 05/07/2018
• Initial Report FDA Received Date: 04/18/2018
• Supplement Report FDA Received Date: 05/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1