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

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/31/2023

Event Type  malfunction  

Manufacturer Narrative

H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that bd maxzero multi-fuse extension set with needleless connector disconnected.The following information was received by the initial reporter with the verbatim: these products are installed at chilren poliklinik, but problem accured at children ward.The valve gets off the extension with very low force.

Event Description

None received these products are installed at chilren poliklinik, but problem accured at children ward the valve gets off the extension with very low force.

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.H3 other text : see h.10.

• Brand Name: BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR
• Type of Device: 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: 18207790
• MDR Text Key: 328983795
• Report Number: 9616066-2023-02250
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K140831
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: MZ9277
• Device Lot Number: 22049315
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1