MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD Q-SYTE EXT SET, LUER-LOK 6 IN MICRO BORE; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 385102

Device Problem Leak/Splash (1354)

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

Event Date 03/05/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(6) h.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.

Event Description

It was reported that bd q-syte ext set, luer-lok 6 in micro bore leaked at connector.The following information was provided by the initial reporter, translated from chinese to english: the patient was transferred to the icu due to a car accident, and a cvc-connected septum needleless closed infusion connector was placed on 3.3, and a leak at the infusion connector was found and replaced on 3.5, without causing any damage to the patient.

• Brand Name: BD Q-SYTE EXT SET, LUER-LOK 6 IN MICRO BORE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• 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: 18996277
• MDR Text Key: 339010195
• Report Number: 9610847-2024-00075
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00382903851027
• UDI-Public: (01)00382903851027
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K013621
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 385102
• Device Lot Number: 3192828
• Date Manufacturer Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1