MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD Q-SYTE EXT SET LUERLOK 6 IN STD BORE; STOPCOCK, I.V. SET

Catalog Number	385101
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 q-syte ext set luerlok 6 in std bore had flow issues i am sending you a material safety report concerning a q-syte bi-directional valve with extension ref 385101, following an incident which occurred on 09/01/2025.The batch number of the device is not known, as it was fitted in the emergency department and the incident occurred in the emergency department.When used to inject iodinated contrast as part of a ct scan, the device could not withstand a pressure of 2.5 ml/s.A bubble formed in the tubing.After checking the data sheet for this medical device, it is stated that it can withstand a flow rate of 445 ml/min, which is much higher than the pressure to which it was subjected.According to the radiology department, this is not an isolated incident.A photograph of the device in question is attached.
Additional Manufacturer Narrative
Investigation results: our quality engineer inspected the 1 physical sample submitted for evaluation.The reported issue of flow issues ¿ fluid blockage was not confirmed upon inspection and testing of the samples.Analysis of the sample showed that the sample passed the leak test and it was determined there is no occlusion that would cause the bubbles referenced by the customer.Bd could not determine a manufacturing related root cause since the reported defect was not confirmed during the evaluation of the sample.The failure is more likely attributed to misuse by the customer, in which the device dose started with a high pressure causing the bubbles.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.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 EXT SET LUERLOK 6 IN STD BORE
• Common Device Name: STOPCOCK, I.V. 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: 21356097
• Report Number: 9610847-2025-00023
• Device Sequence Number: 7835837
• Product Code: FPA
• UDI-Device Identifier: 00382903851010
• UDI-Public: (01)00382903851010
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K013621
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2025

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: 385101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2025
• Supplement Date Received by Manufacturer: 04/09/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 04/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown