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 Defective Component (2292)

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

Event Date 02/20/2024

Event Type  malfunction  

Event Description

It was reported that bd q-syte closed luer access device with septum damage.The following information was provided by the initial reporter, translated from chinese to english: on (b)(6) 2024 at approximately 10:10 am, in the hematology-oncology ward, the patient was admitted for "maintenance chemotherapy for malignancy, diffuse large b-cell lymphoma, hypertension, pulmonary infection, deep vein thrombosis of the lower extremities, osteofascial compartment syndrome, lymphedema of the lower extremities, damage to the nerves of the lower extremities, depressive state, and hepatic insufficiency"."admitted to the hospital, during which the product needs to be used for intravenous infusion therapy.The nurse in charge took out the complete packaging of the septum needleless closed infusion connector and connected it to the picc upper flushing tube according to the normal operation procedure, the liquid leaked out from the periphery of the septum, and after careful observation, he found that the septum of the septum needleless closed infusion connector was concave and could not rebound.After replacing the septum with another needleless closed infusion connector of the same brand, specification and batch, the above phenomenon did not occur again.The timely replacement did not cause serious adverse consequences and did not harm the patient.

Manufacturer Narrative

H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.

• 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: 19084787
• MDR Text Key: 340682254
• Report Number: 1710034-2024-00313
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00382903851003
• UDI-Public: (01)00382903851003
• 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: Other,Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/28/2024

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
• Device Lot Number: 3122411
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/20/2024
• Initial Date FDA Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1