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

Catalog Number	MP1000-C
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd maxplus needless connector was broke the following information was received by the initial reporter with the following verbatim it was reported by customer that while disconnecting heparin line from piv, the neck portion of the line broke off into the iv hub.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
No additional information was provided.
Additional Manufacturer Narrative
It was reported by customer that while disconnecting heparin line from piv, the neck portion of the line broke off into the iv hub.Three photos were received for quality evaluation.The photos provided shows that a male luer connector broke off into the maxplus connector.The photos do not show any issues with the maxplus connector itself.The customer complaint of component damage on the product mp1000-c could not be verified.A root cause analysis was not conducted because the failure seen in the photos is not a failure on the reported product.The broken male luer is a part of a different product.A device history record review could not be performed because the lot number is unknown.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

• 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: 23824838
• Report Number: 9616066-2025-03819
• Device Sequence Number: 9287918
• Product Code: FPA
• UDI-Device Identifier: 10885403223228
• UDI-Public: (01)10885403223228
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K072542
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2026

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: MP1000-C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2025
• Supplement Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown