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	Failure to Disconnect (2541)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2025
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 the bd maxplus needleless connector was difficult to disconnect.The following information was provided by the initial reporter: maxplus could not be removed from catheter hub, had to be removed with forceps.Additional information received from the customer: please share the lot# number if available.We were unable to identify lot number describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.No patient injury or harm, but needleless connector needed to be removed with forceps.
Additional Manufacturer Narrative
One maxplus sample was received for quality evaluation.Visual examination of sample did not indicate any damages.The sample was then connected to corresponding female and male connections to each side of the maxplus connector.There were no issues with connection and disconnection to the sample.The customer complaint of component damage - no leak could not be confirmed.A root cause was not determined because the failure was not replicated.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.; 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: 22800378
• Report Number: 9616066-2025-02401
• Device Sequence Number: 12902534
• Product Code: FPA
• UDI-Device Identifier: 10885403223228
• UDI-Public: (01)10885403223228
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 08/14/2025

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: 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: 07/21/2025
• Supplement Date Received by Manufacturer: 08/14/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 08/15/2025
• 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