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

Catalog Number	385157
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that bd q-syte 15cm small bore bi-ext set collar spins.The following information was provided by the initial reporter: luer lock plug keeps rotating, there was an earlier pir raised, today we received more units from ward side.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Investigation results: our quality engineer inspected the 1 photo and 1 video submitted for evaluation.The reported issue of connection issues was confirmed upon inspection of the samples.Analysis of the sample showed that the male luer does not tighten correctly, the collar keeps rotating and does not tighten the connection.Bd determined that the cause of the failure was the supplier.The supplier will be notified regarding this complaint.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: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 22091755
• Report Number: 9610847-2025-00157
• Device Sequence Number: 15425154
• Product Code: FPA
• UDI-Device Identifier: 00382903851577
• UDI-Public: (01)00382903851577(11)240819(17)270731(10)4214805
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 06/23/2025

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: 385157
• Device Lot Number: 4214805
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2025
• Supplement Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 05/27/2025
• Supplement Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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