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	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd maxzero multi-fuse extension set with needleless connector(s) had separated.The following information was provided by the initial reporter: one incident of a the max zero connector becoming disconnected from extension set.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
Investigation result: one mz9283 sample was received in opened packaging from lot 24039120 for investigation; clear residual fluid was present in the sample.The customer reported that "the max zero connector becoming disconnected from extension set".As part of the investigation, the customer provided a photograph of the affected sample; analysis of the photograph confirmed the customer's experience where one of the maxzero's had separated from the extension set.Visual inspection of the returned sample confirmed the separation between the tubing and maxzero connector; a closer inspection of the tubing at the affected joint, did not identify any obvious signs of residual solvent present.The details of this feedback were forwarded to the manufacturing site for investigation.Following a review of the manufacturing process, their analysis confirmed that the separation is most likely to have been caused by an insufficient amount of solvent having been applied to the tubing joint during the assembly process.This is a manually performed assembly step and is likely to have occurred due to human error.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.Please note, since the manufacture of the affected product, the assembly of this product has moved to an alternative manufacturing site.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.
Event or Problem Description
No additional information.

• 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: 22484894
• Report Number: 9616066-2025-01945
• Device Sequence Number: 12900182
• Product Code: FPA
• UDI-Device Identifier: 10885403230660
• UDI-Public: (01)10885403230660(17)270306(10)24039120
• 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): 08/26/2025

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: 06/18/2025
• Supplement Date Received by Manufacturer: 08/26/2025
• Initial Report FDA Received Date: 07/11/2025
• Supplement Report FDA Received Date: 09/08/2025
• 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