MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD MAXGUARD EXTENSION SET WITH NEEDLELESS Y-SITE(S), STOPCOCK(S) AND MANIFOLD; INTRAVASCULAR ADMINISTRATION SET

Catalog Number MX4436

Device Problem Defective Component (2292)

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

Event Date 03/29/2024

Event Type  malfunction  

Manufacturer Narrative

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 maxguard extension set with needleless y-site(s), stopcock(s) and manifold was damaged the following information was received, by the initial reporter with the following verbatim: rcc received, a complaint via email.Attempted to twist the stopcock to remove it, and the tubing broke off with minimal force.Catalog#: mx4436.

• Brand Name: BD MAXGUARD EXTENSION SET WITH NEEDLELESS Y-SITE(S), STOPCOCK(S) AND MANIFOLD
• 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: 19183568
• MDR Text Key: 341787846
• Report Number: 9616066-2024-00626
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403237478
• UDI-Public: (01)10885403237478
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051499
• 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
• Report Date: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: MX4436
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1