MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD MAXPLUS NEEDLELESS CONNECTOR; INTRAVASCULAR ADMINISTRATION SET

Catalog Number MP1000

Device Problem Defective Component (2292)

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

Event Date 11/20/2023

Event Type  malfunction  

Event Description

It was reported that bd maxplus needleless connector was broken.The following information was received by the initial reporter with the following verbatim: at 8:20 on (b)(6) 2023, the nurse prepared to give the patient an infusion.Before the infusion, she replaced the patient's picc tube with a new bd needleless connector.After the replacement, the nurse flushed the picc tube to see if the line was unobstructed and found that the bd had no needle-free connector.The end of the needle connector connected to the infusion set was broken, causing the flushing fluid to leak out.

Manufacturer Narrative

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

• Brand Name: BD MAXPLUS 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: 18395012
• MDR Text Key: 331675362
• Report Number: 9616066-2023-02436
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 20885403232982
• UDI-Public: (01)20885403232982
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K072542
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/18/2023

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: MP1000
• Device Lot Number: 221018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2023
• Initial Date FDA Received: 12/26/2023
• 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