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

Catalog Number	385162
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the head of the anesthesia technician has clarified that there is an issue with the newly delivered tri extension of bd q syte.It is not functioning as expected and is not locking properly, unlike the previous delivered extensions.The extension is losing its connection and not securing properly, leading to the unexpected disconnection of patient lines, which has been repeated multiple times.This is a significant concern, as it impacts the safety and effectiveness of the hospital operations.
Additional Manufacturer Narrative
H3: if a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
Investigation results: our quality engineer inspected the 3 photos submitted for evaluation.The reported issue of connection issues was confirmed upon inspection of the samples.Analysis of the sample showed that there is a missing ring on the male luer component.This part is supplied to us by a third-party supplier, and they have been made aware of this issue.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.
Event or Problem Description
Additional information: additionally, we have internally conducted a comparison between the old and the new received extension and it seems that there is a difference in the tip of the connection tubing, which has led to the loss of connection.

• 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): 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: 23454762
• Report Number: 9610847-2025-00398
• Device Sequence Number: 20847330
• Product Code: FPA
• UDI-Device Identifier: 00382903851621
• UDI-Public: (01)00382903851621(11)250128(17)271231(10)5008612
• Combination Product (Y/N): N
• Initial Reporter Country: KU
• PMA/510(K) Number: K142527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2026

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: 385162
• Device Lot Number: 5008612
• 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: 10/23/2025
• Supplement Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/28/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown