MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. Q-Syte; Stopcock, I.V. Set

Catalog Number	385163
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
"it was reported that inability to remove the q-syte from the catheter/port needle hub has created potential clinical risks and workflow challenges.Because the q-syte remains attached and cannot be removed, blood sampling is being performed through the q-syte rather than directly from the lumen, which is the institution's standard protocol.In addition, extra flushing is required to clear blood from the lumen and connector.There is concern that using the q-syte for blood sampling and/or leaving it in place longer than intended could increase the risk of infection, although no infection or patient injury has been reported.A further concern is that the q-syte can become firmly locked onto the port needle hub.When healthcare professionals attempt to remove it, significant force may be required, which has resulted in the port needle hub breaking.In these cases, the port needle must be replaced, requiring an additional invasive procedure for the patient.While no adverse patient outcomes have occurred so far, the need for re-accessing the port may expose the patient to an increased risk of complications, including infection, discomfort, and additional procedural intervention.In summary, no actual patient harm has occurred; however, the issue presents a potential risk for infection and other complications, and it may necessitate additional invasive procedures when device replacement is required.".
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

• Brand Name: Q-Syte
• Common Device Name: Stopcock, I.V. Set
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• 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: 50775441
• Report Number: 9610847-2026-00405
• Device Sequence Number: 9488740
• Product Code: FPA
• UDI-Device Identifier: 00382903851638
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K142527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/10/2026

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: 385163
• Device Lot Number: 4246263
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/25/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown