MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. Q-Syte; Set, Administration, Intravascular

Catalog Number	385100
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that bd q-syte closed luer access device component was cracked and leaked.I am writing to inform you of an incident that occurred on (b)(6) 2026.Incident details: it was reported that change of intravenous cyclosporine syringe at 15:00.At around 20:30, the solution was leaking from the pumps onto the floor and the cyclosporine syringe was filled with saline.The q-syte was completely cracked.The child received little or no cyclosporine.Immediate action: line changed.Ciclosporin levels monitored over the following days and doses increased.Apparent immediate consequences: for the patient: underdosing of ciclosporin.
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.B.1 adverse event and product problem.

• 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 ; +1(847)393-5694
• MDR Report Key: 50118019
• Report Number: 1710034-2026-00861
• Device Sequence Number: 21351671
• Product Code: FPA
• UDI-Device Identifier: 00382903851003
• UDI-Public: (01)00382903851003
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K013621
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 385100
• Device Lot Number: Unknown
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/13/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2026
• Supplement Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 08/03/2026
• Supplement Report FDA Received Date: 08/28/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown