MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD MAXZERO PRESSURE RATED EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	MZ5310
Medical Device Problem Codes	Fluid/Blood Leak (1250); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2026
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 pressure rated extension set was loose/ leaking.The following information was received by the initial reporter with the following verbatim: it was reported by the customer that the new bd extension sets md5310 that replaced md5309.The hub is screwed on instead of glued, and we are having issues with them not staying tight and in some cases, boluses actually exploding off the tubing.We have issues with leaking and have even had issues where anticoag meds aren't getting to the patient intra-procedurally.
Additional Manufacturer Narrative
One sample was received for quality evaluation.Visual examination did not indicated any damages or abnormalities.The sample was then primed and connected to a sample bd primary infusion set.A simulated infusion was conducted at a flow rate of 125 ml/hr for 1 hour.There were no signs of leakage, separation, air-in-line or occlusion.Additionally, the sample did not spontaneously separate during the normally handling of the product.The customer complaint of loose component could not be confirmed.Based on the investigation of the sample, a root cause analysis was not conducted because the reported failure could not be replicated.A device history record review for model mz5310 lot number 25089084 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.

• Brand Name: BD MAXZERO PRESSURE RATED EXTENSION SET
• 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: 24499879
• Report Number: 9616066-2026-00560
• Device Sequence Number: 10510070
• Product Code: FPA
• UDI-Device Identifier: 10885403242090
• UDI-Public: (01)10885403242090
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K140831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2026

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: MZ5310
• Device Lot Number: 25089084
• 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: 02/11/2026
• Supplement Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown