MAUDE Adverse Event Report: BECTON DICKINSON Q-SYTE; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	385102
Medical Device Problem Code	Failure to Disconnect (2541)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, when the nurse attempted to reuse the consumable, the infusion connector adhered to the infusion set after connection and could not be separated.After forcible separation, the septum remained stuck to the infusion set end and could not be removed.This prevented normal infusion therapy, resulting in wasted consumables and severely disrupting the infusion process, thereby delaying patient treatment.
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
No additional information.
Additional Manufacturer Narrative
Investigation results: our quality engineer inspected the 1 photo submitted for evaluation.The reported issue of connection issues was confirmed upon inspection of the photo.Analysis of the sample showed that the clinician is pulling the connection but the septum is stuck to the connector.Bd was not able to determine the cause of the failure.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Production records were reviewed, and this batch meets our manufacturing specification requirements.Complaints received for 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 collected data for identification of emerging trends.

• Brand Name: Q-SYTE
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• 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: 23523722
• Report Number: 9610847-2025-00418
• Device Sequence Number: 9732623
• Product Code: FPA
• UDI-Device Identifier: 00382903851027
• UDI-Public: (01)00382903851027(17)290531(10)4211134
• 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): 02/16/2026

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: 385102
• Device Lot Number: 4211134
• 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: 11/05/2025
• Supplement Date Received by Manufacturer: 02/16/2026
• Initial Report FDA Received Date: 11/11/2025
• Supplement Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/19/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown