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

Catalog Number	ME1225
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd maxguard¿ extension set leaked from the filter.This complaint was created to capture the 3rd of 3 related incidents.The following information was provided by the initial reporter: "unable to be primed, beeping occlusion, filter burst open with manual flush, leaking from circle on filter, beeping occlusion, unable to flush, epi and ivf infusing.Epi never reached patient".
Additional Manufacturer Narrative
The customer reported that there was an occlusion and the filter started to leak.One photo was taken by the customer that is unable to verify the customer complaint.No sample has been returned for investigation.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.A device history record review for material# me1225 and lot# 23029211 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 13feb2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.
Event or Problem Description
No additional info.

• Brand Name: BD MAXGUARD¿ EXTENSION 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: 17935023
• Report Number: 9616066-2023-02088
• Device Sequence Number: 6472473
• Product Code: FPA
• UDI-Device Identifier: 10885403236129
• UDI-Public: (01)10885403236129
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 01/23/2024

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: 02/13/2026
• Device Catalogue Number: ME1225
• Device Lot Number: 23029211
• 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: 09/22/2023
• Supplement Date Received by Manufacturer: 01/23/2024
• Initial Report FDA Received Date: 10/13/2023
• Supplement Report FDA Received Date: 01/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2023
• 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