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

Catalog Number	MP1000 CHINA
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: a mp1000 china product was not available for investigation of (b)(4) however, the customer confirmed that the complaint sample was from lot 24045587.The feedback provided by the customer states that, " after connecting the needleless injection cap, fluid flow was obstructed." further information from the customer has stated that complete occlusion was observed during priming using a substance stored at room temperature.The connecting product used was weigao and no visible damages were observed with the product.The details of this feedback were forwarded to the manufacturing site for investigation, where a review of the production records for lot 24045587 did not identify any in-process testing failures or quality deviations which may have caused or contributed to a report of this nature.The root cause of the customer¿s experience could not be determined in this instance as no sample was received for investigation.Without a sample to examine it is not possible to determine whether a manufacturing defect could have caused or contributed to a report of this nature.However, previous investigations have identified that certain designs of male luer can cause flow restriction or occlusion as they can grip onto the piston of the maxplus preventing its proper collapse.This can sometimes be resolved by disconnecting and reattaching the same luer connection which may reposition the luer against the piston and improve the flow, or alternatively by changing the connecting male luer.In this instance, without the complaint sample to examine it has not been possible to conclusively link this feedback to a specific failure mode; however, a review of the customer feedback database indicates that this is a rare occurrence with a small number of similar reports against the mp1000 china product in the past 12 months.
Event or Problem Description
It was reported that the bd maxplus positive pressure connector was occluded.The following information was provided by the initial reporter, translated from chinese to english: due to fatigue, the patient was given infusion treatment using a needle-free connector connected to an indwelling needle infusion set at 11:00 on (b)(6) 2025.It was found that the liquid did not flow smoothly after the needle-free connector was connected.After the needle-free connector was replaced, the liquid flowed smoothly.Additional information received from the customer: please confirm when was the issue identified? during priming or infusion? when primed.Please confirm what medication was being administered during the event? unable to recall.Please confirm if the medication was stored in the refrigerator? if yes, was it allowed to reach room temperature before use? recovered at room temperature.Please confirm the make and model of the connecting products? weigao.Please confirm if there are any visible defects to the device i.E., cracks, flashes, kinks? no please confirm if the connecting product has a luer slip or luer lock connection? luer connector.Please confirm whether the flow was completely or partially blocked? complete.Please confirm if there is any patient impact? no.

• Brand Name: BD MAXPLUS POSITIVE PRESSURE 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: 22501099
• Report Number: 9616066-2025-01996
• Device Sequence Number: 7029423
• Product Code: FPA
• UDI-Device Identifier: 10885403232985
• UDI-Public: (01)10885403232985(10)24045587
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K072542
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/30/2025

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 CHINA
• Device Lot Number: 24045587
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2025
• Initial Report FDA Received Date: 07/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/24/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown