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

Catalog Number	385100
Medical Device Problem Codes	Complete Blockage (1094); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
It was reported that bd q-syte closed luer access device septum did not rebound and fluid did not infuse.(b)(6) 2026, 15:15, ready for the patient infusion treatment, connected to the septum needleless closed infusion cap, first with a syringe to flush the tubing, and then connected to the infusion set, found that the infusion does not drip, remove the infusion set found that the internal parts of the septum needleless closed injection cap did not rebound out, resulting in the fluid does not drip, that is, to replace the new septum needleless closed infusion cap to the patient for the infusion treatment, replacement after replacement, the infusion was smooth.

• Brand Name: Q-SYTE
• Common Device Name: 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: 25679114
• Report Number: 1710034-2026-00749
• Device Sequence Number: 9722166
• Product Code: FPA
• UDI-Device Identifier: 00382903851003
• UDI-Public: (01)00382903851003(11)241008(17)290731(10)4274492
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K013621
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: 385100
• Device Lot Number: 4274492
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2026
• Supplement Date Received by Manufacturer: 07/07/2026
• Initial Report FDA Received Date: 07/01/2026
• Supplement Report FDA Received Date: 07/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/08/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown