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	MZ9277
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Three mz9277 samples were received in opened packaging from lot: 22049315, for investigation; no residual fluid was present in all three sets.The customer reported that "the valve gets off the extension with very low force".A visual inspection of the returned samples confirmed the customer experience as the tubing was separated from the maxzero tubing joint (appendix 1).A closer inspection of the tubing found that was residual solvent at the joint (appendix 2).The details of this feedback were forwarded to the manufacturing site for investigation.In this instance, a definitive root cause could not be determined, however it is possible that the separation occurred as a result of an inconsistent application of solvent coupled with a pulling force.This is a hand assembled joint and therefore the customer's experience is likely to have been contributed to by human error.A review of the production records for lot 22049315 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.
Event or Problem Description
It was reported that bd maxzero multi-fuse extension set with needleless connector disconnects.The following information was received by initial reporter with the following verbatim: these products are installed at chilren poliklinik, but problem accured at children ward.The valve gets off the extension with very low force.

• 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: 18686226
• Report Number: 9616066-2024-00218
• Device Sequence Number: 6396461
• Product Code: FPA
• UDI-Device Identifier: 10885403240799
• UDI-Public: (01)10885403240799
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K140831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/08/2024

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 Expiration Date: 04/25/2025
• Device Catalogue Number: MZ9277
• Device Lot Number: 22049315
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2024
• Initial Report FDA Received Date: 02/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown