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

Catalog Number	385100
Medical Device Problem Codes	Leak/Splash (1354); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the q-syte septum was separated and leaked.The patient underwent removal of the right tibial internal fixation device on (b)(6) 2026.A venous analgesia pump was left in place postoperatively, and this needle-free, sealed infusion connector with a diaphragm was used between the analgesia pump and the intravenous catheter.At approximately 9:00 a.M.On (b)(6) 2026, the patient reported fluid leakage at the site of the septum.A bedside examination initially suggested that the leakage was due to poor fixation.After re-fixing the septum, leakage persisted, so the septum was replaced.Upon inspection, it was found that the central body of the original septum had become detached from the cap end, resulting in the leakage.
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.
Additional Manufacturer Narrative
Investigation summary: the reported defect could not be refuted nor confirmed in the absence of a sample.The root cause cannot be determined for an unconfirmed defect.A complaint history check was performed, and this is the 1st related complaint reported with the defect/condition of loose component - leak with lot 5213928 regarding item #385100.Lot 5213928 is a final product lot.No related quality issues or deviations were found during the manufacture of the subassembly batches.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: 24932772
• Report Number: 1710034-2026-00436
• Device Sequence Number: 16119266
• Product Code: FPA
• UDI-Device Identifier: 00382903851003
• UDI-Public: (01)00382903851003(10)5213928
• 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): 05/05/2026

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: 5213928
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2026
• Supplement Date Received by Manufacturer: 05/05/2026
• Initial Report FDA Received Date: 04/20/2026
• Supplement Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown