MAUDE Adverse Event Report: 36 IN 20 DROP SECONDARY SET; INTRAVASCULAR ADMINISTRATION SET

Model Number	MS3500
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device expiration date: unknown.Device manufacture date: unknown.Investigation summary: no product or photo was returned by the customer.The customer complaint of the secondary tubing became disconnected at the fluid chamber causing medication to leak out of the chamber and backflow out of the tubing side could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on model ms3500 because a valid lot number was not provided by the customer.The root cause of this failure could not be identified without a failure investigation.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Investigation conclusion: due to no sample being received, an investigation could not be performed, and a root cause could not be determined.
Event or Problem Description
It was reported that the 36 in 20 drop secondary set experienced leakage.The following information was provided by the initial reporter: secondary tubing became disconnected at the fluid chamber causing medication to come gushing out of chamber on the chamber side and backflow out of the tubing side.Did not reach the patient.

• Brand Name: 36 IN 20 DROP SECONDARY SET
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 12298919
• Report Number: 9616066-2021-51751
• Device Sequence Number: 3612028
• Product Code: FPA
• UDI-Device Identifier: 50885403222601
• UDI-Public: 50885403222601
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K790582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/27/2021

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: Other
• Device Model Number: MS3500
• Device Catalogue Number: MS3500
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2021
• Initial Report FDA Received Date: 08/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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