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

Catalog Number	MA3131
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd maxguard administration set leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: late 60's female with history of atrial fibrillation.Procedure: ablation af.Maxguard 10cc drop administration tubing leaking at the leuer lock hub.The tubing is sterile and connected to a side port of a sheath that extends into the left atrium of the heart.This could potentially introduce air into the body.Tubing removed without difficulty and a new set used.No known harm to patient.Manufacturer response for set, administration, intravascular, maxguard (per site reporter) will obtain.
Additional Manufacturer Narrative
E.4.: the initial reporter also notified the fda on 20-feb-2023 medwatch report # (b)(4).H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
Investigation summary: no photo or sample was received for the customer's complaint of leakage.Without further information like a physical sample for investigation, the complaint cannot be verified and root cause of this failure remains unknown.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 while using bd maxguard administration set leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: late 60¿s female with history of atrial fibrillation.Procedure: ablation af.Maxguard 10cc drop administration tubing leaking at the leuer lock hub.The tubing is sterile and connected to a side port of a sheath that extends into the left atrium of the heart.This could potentially introduce air into the body.Tubing removed without difficulty and a new set used.No known harm to patient.Manufacturer response for set, administration, intravascular, maxguard (per site reporter) will obtain.

• 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 ; 8448235433
• MDR Report Key: 16757426
• Report Number: 9616066-2023-00709
• Device Sequence Number: 11576111
• Product Code: FPA
• UDI-Device Identifier: 10885403235825
• UDI-Public: (01)10885403235825
• 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): 05/23/2023

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: Health Professional
• Device Expiration Date: 06/23/2025
• 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: 03/29/2023
• Supplement Date Received by Manufacturer: 05/23/2023
• Initial Report FDA Received Date: 04/17/2023
• Supplement Report FDA Received Date: 06/06/2023
• 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