MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. EXT SET DEHP FREE; INTRAVASCULAR ADMINISTRATION SET

Model Number	11088483
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	03/29/2021
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: two samples were received for quality investigation.The customer complaint of discoloration was verified by visual inspection.Inspection of the female luer adapter showed signs of being yellowish in color in comparison to the rest of the tubing.A device history record review for model 11088483 lot number 20105807 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 11oct2020.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 the discoloration of the tubing can be caused during the sterilization process.Sterilization can be cause the tubing to appear slightly yellowish in appearance.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that the ext set¿¿dehp free was discolored at the tubing connection site.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: " opened another one and i could see that there was a discoloration at the site where it should hook onto the tubing.I flushed it and was unable to determine if it was leaking.

• Brand Name: EXT SET DEHP FREE
• 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: 11729711
• Report Number: 9616066-2021-50818
• Device Sequence Number: 4253824
• Product Code: FPA
• UDI-Device Identifier: 50885403234666
• UDI-Public: 50885403234666
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K790108
• 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): 04/16/2021

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 Expiration Date: 10/11/2023
• Device Model Number: 11088483
• Device Catalogue Number: 11088483
• Device Lot Number: 20105807
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2021
• Initial Report FDA Received Date: 04/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1