MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	MZ9279
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation result: one mz9279 sample was received without packaging; some residual was present in the line and no connecting product was available for investigation.The customer did not provide any lot information but reported that "extension set one lumen blocked after opening unable to be flushed." a visual inspection of the returned samples did not identify any product defects or manufacturing issues which could have caused or contributed to the customer's experience.The returned samples were subjected to functional testing by priming and flushing using a 50ml bd plastipak syringe and no restriction or occlusion was observed.The details of this feedback were forwarded to the manufacturing site for investigation.In this instance, a definitive root cause could not be identified as testing of the returned samples did not identify any product defects or quality deviation that could have contributed to the customer¿s experience.The lot number was not available and therefore it is not possible to perform a review of the production documentation for this particular product.A review of the customer feedback database indicates that this is an isolated feedback with no further reports of this nature against the mz9279 product in the past 12 months.
Event or Problem Description
No additional information.
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 maxzero multi-fuse extension set with needleless connector was occluded.The following information was provided by the initial reporter: extension set one lumen blocked after opening unable to be flushed.

• Brand Name: BD MAXZERO MULTI-FUSE EXTENSION SET WITH 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: 22480303
• Report Number: 9616066-2025-01943
• Device Sequence Number: 8554846
• Product Code: FPA
• UDI-Device Identifier: 10885403230622
• UDI-Public: (01)10885403230622
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K140831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2025

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: MZ9279
• 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: 06/18/2025
• Supplement Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 07/11/2025
• Supplement Report FDA Received Date: 07/21/2025
• 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