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

Catalog Number	MP1000-C
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2025
Type of Reportable Event	Malfunction
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
It was reported that bd maxzero needless connector was leaking.The following information was received by the initial reporter with the following verbatim it was reported by customer that be advised we have recently noted an increasingly common defect in the bd mp1000-c maxplus clear needless connector.According to staff reports, the device leaks at its seam.
Additional Manufacturer Narrative
Investigation summary: 260 unused mp1000-c (batches 25015121, 25015319, 25035068) connectors were received and tested by our quality team.The sets were injected with saline using a 50ml syringe and closing the male luer side to inhibit flow through set in effort to induce leak.All sets passed the tests and the complaint could not be verified.The root cause of this issue remains unknown without the affected sample for testing.The production history was analyzed and there were no issues found during quality inspections that would lead to this issue.
Event or Problem Description
Samples.

• Brand Name: BD MAXPLUS NEEDLESS CONNECTOR
• 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: 22843048
• Report Number: 9616066-2025-02478
• Device Sequence Number: 14658336
• Product Code: FPA
• UDI-Device Identifier: 10885403223228
• UDI-Public: (01)10885403223228(17)300106(10)25015121
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K072542
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2026

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: 25015121
• 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: 07/28/2025
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 08/19/2025
• Supplement Report FDA Received Date: 01/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/07/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown