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

Catalog Number	MZ9283
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2025
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 maxzero multi-fuse extension set with needleless connector(s) was occluded.The following information was provided by the initial reporter: multiple incidents of 4-way connector blocking and unable to be flushed.
Additional Manufacturer Narrative
Medical device lot # & medical device expiration date added in section d investigation result: one mz9283 sample was received for investigation, in which the customer has stated: "multiple incidents of 4-way connector blocking and unable to be flushed." no packaging was received with the sample and the customer did not provide a lot number with the initial feedback.Residual fluid was present in the line.The returned samples were subjected to functional testing by priming and flushing using a 50ml bd plastipak syringe, which confirmed the customer's experience as one of the four tubing lines was found to be occluded.Further examination found the set to be occluded at the joint to the bcv component; however no obvious signs of excess solvent were present at the affected joint when it was separated, with flow resuming unimpeded.The details of this feedback were forwarded to the manufacturing site for investigation.In this instance, a definitive root cause for the customer's experience could not be determined, however the occlusion is likely to have been caused by an excess amount of solvent having been applied at the affected joint during manufacture; this is a hand assembled joint and is likely to have occurred due to human error.A lot number was not provided as part of the investigation; however a review of the laser id from the maxzero component confirmed that the sample was from lot 24039120.A review of the production records for lot 24039120 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.The quality team at the manufacturing site has been informed of this report in order to be aware of the reported feedback during future production of this product.A review of the customer feedback database indicates that this is an isolated feedback with no further reports of this nature against the mz9283 product in the past 12 months.

• Brand Name: BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR(S)
• 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: 21414235
• Report Number: 9616066-2025-00290
• Device Sequence Number: 18273520
• Product Code: FPA
• UDI-Device Identifier: 10885403230660
• UDI-Public: (01)10885403230660
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2025

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: MZ9283
• Device Lot Number: 24039120
• 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: 01/30/2025
• Supplement Date Received by Manufacturer: 04/23/2025
• Initial Report FDA Received Date: 02/19/2025
• Supplement Report FDA Received Date: 05/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown