MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD Q-SYTE CLOSED LUER ACCESS DEVICE; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 385100

Device Problem Leak/Splash (1354)

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

Event Date 03/05/2024

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 the bd q-syte closed luer access device leaked.The following information was provided by the initial reporter translated from french to english: "on the infusion set-up: leak at the bd q syte bidirectional valve.Part of the infusion leaked onto the floor and was therefore not administered to the patient.A priori no air bubbles in the infusion line.It happened twice." during use immediate action: check the rest of the assembly and replace the defective part.Defective part.Immediate consequences apparent: intravenous treatment not administered in full no clinical consequences.

• Brand Name: BD Q-SYTE CLOSED LUER ACCESS DEVICE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19192926
• MDR Text Key: 341191617
• Report Number: 1710034-2024-00361
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00382903851003
• UDI-Public: (01)00382903851003
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K013621
• 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
• Report Date: 04/10/2024

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: Health Professional
• Device Catalogue Number: 385100
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/02/2024
• Initial Date FDA Received: 04/26/2024
• 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