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

Catalog Number	MP9220-C
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd maxguard multi-fuse extension set with needleless connector was damaged.The following information was provided by the initial reporter: the leuer end of the bd maxplus tri-fuse extension set was cracked.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
It was reported by customer that the luer end of the bd maxplus tri-fuse extension set was cracked.Two samples were received for quality evaluation.Visual inspection of the samples indicate that the male luer adapter securement collar was cracked.The customer complaint of component damage was confirmed.Based on the information provided and the analysis of the samples received, the root cause of the cracks in the luer collar are caused by using alcohol / antiseptic on the corresponding connection and not allowing for a sufficient time to dry.This causes the plastic to become brittle and crack.The supplier has been contacted and the bd clinical team has been made aware in case further training or information is deem necessary.A device history record review for model mp9220-c, lot number 25019330 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production 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.
Additional Manufacturer Narrative
No product or photo was returned by the customer.The customer complaint of component damage - leak could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on material mp9220-c because the lot number is unknown.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.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
No additional information provided.

• Brand Name: MAXPLUS
• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 22301952
• Report Number: 9616066-2025-01640
• Device Sequence Number: 18576817
• Product Code: FPA
• UDI-Device Identifier: 10885403240782
• UDI-Public: (01)10885403240782
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/07/2025

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: MP9220-C
• Device Lot Number: UNKNOWN
• 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: 05/28/2025
• Supplement Date Received by Manufacturer: 07/03/2025; 10/07/2025
• Initial Report FDA Received Date: 06/20/2025
• Supplement Report FDA Received Date: 07/11/2025; 10/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown