MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. Q-SYTE; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	385151
Medical Device Problem Codes	Disconnection (1171); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that bd ext set 15cm small bore spin nut separated and leaked it was reported that the patient had a cannula with a tailed spiral q pulse attached to it.Two different fluids dripped into the cannula through the q-syte at the same time.The cannula was put in in the evening and its functionality was checked during the evening and night and it worked flawlessly.At night, when we went to the room to take off the second fluid drip as planned, it was noticed that the cannula dressings, the patient's shirt and sheet were heavily wet.The cannula was protected with gauze, so the dressings were dismantled and it was noticed that the q-cyte had completely detached from the cannula and the fluids had been able to leak past the cannula.As a result of the detachment of the q-syte, the cannula no longer worked.As a result of the incident, the patient had to be woken up at night and the cannula removed, as well as change into dry clothes and bed sheets.However, the cannula did not have to be replaced during the night, as enough fluids had already been emitted.Description of the consequence of the incident or a possible consequence for the patient/client or other person delayed hydration, possible risk of infection.Material number: 385151 lot number: 3107967 date of event: 9.12.2025.
Additional Manufacturer Narrative
Investigation results: bd was not able to confirm the customer¿s indicated failure mode since no photo nor sample was provided to perform a proper investigation.An investigation on the actual device would be necessary to confirm the reported failure mode.Quality records have been consulted for tracking and trending purposes but issues like this are not detected which means pretty low occurrence.We will keep monitoring the manufacturing process and in case any emerging trend is detected, further actions will be taken if necessary.
Event or Problem Description
No additional information.

• Brand Name: Q-SYTE
• Common Device Name: INTRAVASCULAR ADMINISTRATION 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): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 23960619
• Report Number: 9610847-2026-00001
• Device Sequence Number: 15855915
• Product Code: FPA
• UDI-Device Identifier: 00382903851515
• UDI-Public: (01)00382903851515(11)230426(17)260331(10)3107967
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K142527
• 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
• Report Date (Section B): 02/10/2026

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 Expiration Date: 03/31/2026
• Device Catalogue Number: 385151
• Device Lot Number: 3107967
• 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: 12/15/2025
• Supplement Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/26/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown