MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. TRI-PORT EXT W/3 VLV PORTS; INTRAVASCULAR ADMINISTRATION SET

Model Number	20038E
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: a complaint of a cosmetic issues was received from the customer.A photo was provided for investigation.In the photo it was observed that two of the y-sites are tinted yellow.A device history record review for model 20038e lot number 21015535 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 09jan2020.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 was not identified as no product was returned.
Event or Problem Description
It was reported that a tri-port ext w/3 vlv ports had foreign matter at an unspecified time.The following was reported by the initial reporter: "it was reported that the smart site connector is yellow tinted.Verbatim: yellow portion of smartsite connector".

• Brand Name: TRI-PORT EXT W/3 VLV PORTS
• 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: 11418414
• Report Number: 9616066-2021-50359
• Device Sequence Number: 4416885
• Product Code: FPA
• UDI-Device Identifier: 37613203011984
• UDI-Public: 37613203011984
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K960280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/25/2021

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: Health Professional
• Device Expiration Date: 01/09/2024
• Device Model Number: 20038E
• Device Catalogue Number: 20038E
• Device Lot Number: 21015535
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2021
• Initial Report FDA Received Date: 03/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1