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

Catalog Number	MP1000-C
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd maxplus needleless connector had separated.The following information was provided by the initial reporter: quadfuse iv connection plastic luer lock fell off causing the quadfuse with meds to become disconnected from the patient iv.This has happened a few times recently.Injuries or adverse event: no item: mp1000-c quantity affected: (b)(4).Serial/lot number:.Additional information received from the customer: the lot number was unknown.To my knowledge, this happened twice.Harm level: none to patient or nurse.What was the medication/fluid in use at the time of the event? it was not chemo.It was likely sedation and iv fluids.
Additional Manufacturer Narrative
If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
Two samples of an unknown quadfuse assemblies were submitted with 10 maxplus mp1000-c connectors connected to each of the female luer connections.It is noted that the non-bd quadfuse tubing has damage on the male luer adapters of those samples, but as this is not a bd component it will not be evaluated in this investigation.Each of the maxplus connectors were tested for leakage and occlusion.There were no issues identified.The samples of the mp1000-c were then connected to samples of bd infusion sets to see if they would separate during connector or when fluid was pushed through the assembly.There was no connection issues or separation with the samples submitted.The customer complaint of separation was not confirmed on the samples of mp1000-c submitted.No root cause analysis was conducted because the reported failure was not confirmed on the mp1000-c connectors.A device history record review could not be performed because the lot number is unknown.

• Brand Name: BD MAXPLUS NEEDLELESS CONNECTOR
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS S.A DE C.V.; parque sur, el realito; blvd. 2000; tijuana 22250 ; MX 22250
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS S.A DE C.V.; parque sur, el realito; blvd. 2000; tijuana 22250 ; MX 22250
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 23416397
• Report Number: 9616066-2025-03307
• Device Sequence Number: 16019566
• 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: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2026

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: 10/08/2025
• Supplement Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown