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	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that bd maxguard administration set tubing disconnected from the spike.The following information was provided by the initial reporter: ¿bd maxguard 10 drop iv tubing disconnected from spike when using for albumin, happened before connection to patient.¿.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
(b)(4).- follow up mdr for device evaluation.A sample was received and tested by our quality team.The set was separated from drip chamber upon receipt and the customer's complaint was verified.The separated tubing was analyzed under microscope and the tubing seemed to lack necessary solvent where it was supposed to be secured to the drip chamber.Set manufacturer was contacted and root cause of failure was confirmed as an improper application of solvent by operator during the portion of assembly joining drip chamber with tubing.A quality alert was initiated to reinforce correct assembly by involved personnel.A device history record review for model ma3131 lot number 22089473 was performed.The search showed that a total of (b)(4)in 1 lot number was built on 25aug2022.There were no quality notifications issued for the failure mode reported by the customer during the build of this set.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.

• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17674714
• Report Number: 9616066-2023-01838
• Device Sequence Number: 14963721
• Product Code: FPA
• UDI-Device Identifier: 10885403235825
• UDI-Public: (01)10885403235825
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2024

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: 08/25/2025
• Device Catalogue Number: MA3131
• Device Lot Number: 22089473
• 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: 08/21/2023
• Supplement Date Received by Manufacturer: 01/22/2024
• Initial Report FDA Received Date: 09/01/2023
• Supplement Report FDA Received Date: 02/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2022
• 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