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

Catalog Number MZ9267

Device Problem Defective Component (2292)

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

Event Date 12/27/2023

Event Type  malfunction  

Manufacturer Narrative

E1: initial reporter facility name - (b)(6).H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Event Description

It was reported that bd maxzero multi-fuse extension set broke the following information was received by the initial reporter with the following verbatim: over the last 2 months we have experienced issues with two products.First, on one patient the medication tubing (mz9267) luer lock device fall off the tubing.It looks like the device was not fused well to the tubing.Second, the luer hub that twists on the quadfuse (mz9283) broke into multiple pieces while in use on a patient.I am not sure if a hemostat was used to loosen the luer or if it was damaged during transit.

Manufacturer Narrative

The customer reported that the sample separated.One sample model mz9267 was returned for investigation.The set was examined for defects and abnormalities.The female luer was separated from the male luer.No other defects or abnormalities were observed.Visual inspection under the microscope revealed no signs of solvent.The customer complaint was verified and a quality notification was sent to the manufacturer.From the manufacturer's investigation, the possible root cause is due to the incomplete insertion caused by poor lubrication due to opportunities in the solvent dispenser.A quality alert was created on february 19, 2024, to reinforce the correct solvent application method and avoid the incomplete insertion between components.As a corrective action, there was a change of solvent dispenser from mdgn to medica.

Event Description

No additional info.

• Brand Name: BD MAXZERO MULTI-FUSE EXTENSION SET
• 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: 18536086
• MDR Text Key: 333150389
• Report Number: 9616066-2024-00028
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140831
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/01/2024

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
• Device Operator: Other
• Device Catalogue Number: MZ9267
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/27/2023
• Initial Date FDA Received: 01/18/2024
• Supplement Dates Manufacturer Received: 03/01/2024
• Supplement Dates FDA Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1