MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 5.5" ( 14 CM) MAXGUARD T-CONN BI-FUSE EX; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	MXT1006
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that 5.5" ( 14 cm) maxguard t-conn bi-fuse ex tubing separated.The following information was provided by the initial reporter: it was reported that the microbore extension seem to have issues with the leur lock collar coming off or becoming unattached.
Additional Manufacturer Narrative
Investigation summary: two used extension sets, were received by the customer for investigation.One set was returned attached to a stopcock.Neither set matched the expected model: mxt1006.The sets were visually inspected and no defects were observed.The components were examined and functionally tested.The sets functioned as designed and no defects were observed.The customer's complaint of issues with the leur lock collar coming off or unattached and sometimes cracking could not be verified.A device history record review could not be performed because a lot number was not provided by the customer.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 5.5" ( 14 cm) maxguard t-conn bi-fuse ex tubing separated.The following information was provided by the initial reporter: it was reported that the microbore extension seem to have issues with the leur lock collar coming off or becoming unattached.

• Brand Name: 5.5" ( 14 CM) MAXGUARD T-CONN BI-FUSE EX
• 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: 12081634
• Report Number: 9616066-2021-51409
• Device Sequence Number: 4358891
• Product Code: FPA
• UDI-Device Identifier: 10885403274756
• UDI-Public: 10885403274756
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• 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,Followup
• Report Date (Section B): 06/30/2021

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 Catalogue Number: MXT1006
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2021
• Initial Date Received by Manufacturer: 06/01/2021
• Supplement Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 06/28/2021
• Supplement Report FDA Received Date: 07/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1