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

Catalog Number	385100
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2026
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 the q-syte leaked.We are reporting a q-syte malfunction when attached to an umbilical vein catheter.While rounding on the neonate, pink blood tinged tpn fluid was found on the blood.The nurse attempted to tighten the connections to stop the leaking, but this did not resolve the issue.The q-syte was changed out and leaking stopped.Can you please provide an exact date of incident: (b)(6) 2026.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
The complaint of a damaged q syte connector was confirmed.However, the root cause could not be determined.Two q syte connectors were provided for investigation.One connector was received in sealed unit packaging, and no damage or defects were identified on the sample.The other sample exhibited a breach in the septum, which allowed fluid to leak.As the device has been opened, it could not be determined with certainty whether the damage originated during manufacturing or use of the device.A review of the production records from the implicated lot showed no related quality issues or process deviations during manufacturing.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.

• 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: 24592839
• Report Number: 1710034-2026-00272
• Device Sequence Number: 9532093
• Product Code: FPA
• UDI-Device Identifier: 00382903851003
• UDI-Public: (01)00382903851003(11)231115(17)280930(10)3305926
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K013621
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2026

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: 3305926
• 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: 03/02/2026
• Supplement Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 03/13/2026
• Supplement Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown