MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD Q-SYTE 15CM SMALL BORE BI-EXT SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	385157
Medical Device Problem Codes	Leak/Splash (1354); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3.The date received by manufacturer has been used for this field.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 had a poor connection with leak.The following information was provided by the initial reporter: the luer lock fixator doesn't get fixed to the cannula, the thread keeps rotating and gets disconnected, which leads to leakage of blood and medications.08-may-2025- received an email response.Quantity involved-1.Can you confirm is there any patient impacted? - no.Can you confirm that there are any serious injuries that occur to the patient? no.
Additional Manufacturer Narrative
Investigation results: our quality engineer inspected the 1 physical sample submitted for evaluation.The reported issue of connection issues was confirmed upon inspection and testing of the sample.Analysis of the sample showed that when a connection was made to another device, the male luer keeps rotating and does not fix correctly.Because the customer also mentioned leakage, a leak test with air/water was performed and although the connect was not properly fixed, a leak was not observed in the sample returned.Bd determined that the cause of the failure was supplier related.The supplier has been notified of this reported defect.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.
Event or Problem Description
No additional information.

• Brand Name: BD Q-SYTE 15CM SMALL BORE BI-EXT SET
• 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: 22084658
• Report Number: 9610847-2025-00155
• Device Sequence Number: 12446554
• Product Code: FPA
• UDI-Device Identifier: 00382903851577
• UDI-Public: (01)00382903851577(11)240930(17)270831(10)4246260
• 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): 07/18/2025

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: 4246260
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2025
• Supplement Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 05/26/2025
• Supplement Report FDA Received Date: 07/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown