MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C. EXTENSION SET W/.2MF, SMARTSITE & TEXIUM; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	20350ET
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.Device manufacture date: unknown.Investigation summary: the complaint of leakage near the filter was received from the customer.No product or photo was returned by the customer.The customer complaint of leakage 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 20350et because a lot number was not provided by the customer.The root cause of this failure was not identified as no product was returned.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: no product will be returned per customer.No investigation was performed.Root cause description: the root cause of this failure was not identified as no product was returned.
Event or Problem Description
It was reported that the extension set w/.2mf, smartsite & texium experienced leakage.The following information was provided by the initial reporter: the customer has the defective set however it has chemo in it.It leaked where the tubing meets/is fused with the filter.

• Brand Name: EXTENSION SET W/.2MF, SMARTSITE & TEXIUM
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.; blvd. insurgentes 20351; tijuana, null 22244 ; MX 22244
• MDR Report Key: 10591200
• Report Number: 9616066-2020-02877
• Device Sequence Number: 14347844
• Product Code: FPA
• UDI-Device Identifier: 10885403229756
• UDI-Public: 10885403229756
• Combination Product (Y/N): N
• Initial Reporter State: DC
• 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,user faci
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 09/04/2020

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 Catalogue Number: 20350ET
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other