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	MZ9278
Medical Device Problem Code	Separation Problem (4043)
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
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) separated.The following information was provided by the initial reporter: one of the blue connectors fell off the line.
Additional Manufacturer Narrative
Investigation result: one mz9278 sample was received without packaging for investigation; some sticky residual fluid was present in the tubing.The customer reported that the affected sample was from lot 24039219 and that "one of the blue connectors fell off the line." additional feedback indicated that this occurred during infusion of saline and propofol.As part of the investigation, the customer provided a photograph of the affected sample which indicated a set with a maxzero separated from the tubing.A visual inspection of the returned sample confirmed the customer's experience as one of the maxzero's had separated from the rest of the set.A close inspection of the joint identified no obvious signs of residual solvent present on the tubing joint.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 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 24039219 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 reported lot, the product has been transferred to an alternative manufacturing site; however quality team will continue to monitor the incoming feedback and remain vigilant to reports of this nature.A review of the customer feedback database indicates that this is an isolated feedback with no further reports of this nature against the mz9278 product in the past 12 months.
Event or Problem Description
Please confirm how the fault was identified? when priming lines connector fell off.Please confirm when the fault was identified during priming or during infusion? if during infusion, how long into the infusion? during priming.Please confirm if there is any visible damage on the set ¿ such as cracks, flashes or deformation of the piston? nowas there any patient harm? no.Did the issue occur whilst in clinical use and patient onnetion? no on priming.Was the issue identified with the user present and able to intervene? yes.Was there any over or under infusion noted? no.Was there any leakage? yes.What fluid was being primed? saline and propofol.

• 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: 21723942
• Report Number: 9616066-2025-00664
• Device Sequence Number: 9394588
• Product Code: FPA
• UDI-Device Identifier: 10885403240812
• UDI-Public: (01)10885403240812(11)240312(17)270312(10)24039219
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 05/22/2025

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: MZ9278
• Device Lot Number: 24039219
• 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: 03/10/2025
• Supplement Date Received by Manufacturer: 05/22/2025
• Initial Report FDA Received Date: 03/28/2025
• Supplement Report FDA Received Date: 06/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown