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

Catalog Number	385100
Medical Device Problem Codes	Backflow (1064); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2026
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 q-syte leaked.Radiology have advised that leaking and backflow occurred from the q-syte when iv contrast was given prior to ct via a peripheral line (with a y-connector) by power injection.This resulted in a delay to the ct scan while the q-syte was changed.
Additional Manufacturer Narrative
The complaint of leaking and backflow could not be confirmed from the photograph that was provided for investigation.The photo showed one q-syte connector with evidence of use.There was no supporting evidence to confirm leakage from the q-syte connector.Without a physical sample, functional testing could not be completed.Although the photograph does not support the complainant¿s description of the reported event, the complaint has been documented and will continue to be monitored as part of ongoing efforts to identify potential manufacturing related issues.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Complaints received about this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the data collected for identification of emerging trends.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
Investigation summary: root cause couldn't be determined due to unavailability of sample information.A complaint history record (chr) review could not be performed as no batch/lot number was made available for this reported event.A device history record (dhr) review could not be performed as no batch/lot number was made available for this reported event.A review of the applicable risk documents indicates that the potential risk of the reported event was assessed appropriately in the risk management documentation.
Event or Problem Description
No additional information.

• 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: 24845946
• Report Number: 1710034-2026-00402
• Device Sequence Number: 12998473
• Product Code: FPA
• UDI-Device Identifier: 00382903851003
• UDI-Public: (01)00382903851003
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K013621
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/07/2026

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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2026
• Supplement Date Received by Manufacturer: 04/21/2026; 05/07/2026
• Initial Report FDA Received Date: 04/11/2026
• Supplement Report FDA Received Date: 04/21/2026; 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown