MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 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	06/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: na.Investigation summary: no product or photo was returned by the customer.The customer complaint of separation at the drip chamber in packaging could not be verified due to the product not being returned for failure investigation.A device history record review for model ms3500 lot number 20103261 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on (b)(6) 2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.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 component separation the following information was provided by the initial reporter: tubing taken out of packaging and tubing was disconnected from the spike chamber.

• Brand Name: 36 IN 20 DROP SECONDARY SET
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• MDR Report Key: 12215105
• Report Number: 9616066-2021-51615
• Device Sequence Number: 4136966
• 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): 06/29/2021

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: 20103261
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2021
• Initial Report FDA Received Date: 07/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1