MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD MAXGUARD¿ ADMINISTRATION SET; INTRAVASCULAR ADMINISTRATION SET

Model Number	MA3131
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd maxguard¿ administration set experienced leakage.The following information was provided by the initial reporter: when this sterile iv tubing is connected to a stopcock, it leaks around the threading even if it is threaded/tightly correctly.
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
H6: investigation summary four photos were received with the customer's complaint regarding the ma3131 infusion set.There is no photo of the leak in action, but the provided information is sufficient to verify that a leak occurred as customer mentioned.Without further information like a physical sample for testing, it is difficult to trace the root cause to a fault in design but rather the new intended design of this set.The male luer end of this set has been modified from a spin collar to a fixed male luer connection and this has been a known confusion with customers who are used to the original configuration.A device history record review for model ma3131 lot number 22069490 was performed.There were no quality notifications issued for the failure mode reported by the customer during the build of this set.
Event or Problem Description
It was reported that the bd maxguard¿ administration set experienced leakage.The following information was provided by the initial reporter: when this sterile iv tubing is connected to a stopcock, it leaks around the threading even if it is threaded/tightly correctly.

• Brand Name: BD MAXGUARD¿ ADMINISTRATION 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
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16064812
• Report Number: 9616066-2022-02086
• Device Sequence Number: 17802091
• Product Code: FPA
• UDI-Device Identifier: 50885403235823
• UDI-Public: 50885403235823
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K083765
• 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): 01/27/2023

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: 06/23/2025
• Device Model Number: MA3131
• Device Catalogue Number: MA3131
• Device Lot Number: 22069490
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2022
• Supplement Date Received by Manufacturer: 01/27/2023
• Initial Report FDA Received Date: 12/28/2022
• Supplement Report FDA Received Date: 02/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown