MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. EXT EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	390220
Medical Device Problem Codes	Leak/Splash (1354); Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It is reported that ext extension set - basic - leakage - flow issues - fluid blockage.Leaky iv (brand bd) scan was diagnostic and ran fine but pillows were wet after injection.This is an ongoing issue with this particular iv being used.This has been escalated.Imaging services put in an sbar to use another iv system.We haven't heard back to see if this can be changed.This continues to occur and causes the contrast to leak over the patient.Clean up and delay of scan.At times the iv needs to be changed.Education has been done in the ed to make sure the iv is tightened.It seems to be a supply issue because it continues to happen with this iv system.Was there injury? reached the individual but did not cause harm what was the medication/fluid in use at the time of the event? customer responded on (b)(6): 1: when we are testing the iv ext set to see if we can use the iv is saline and we are hand pushing.At times if the lab or someone else has used the ext set the clear rubber inside is moved in a way that we can¿t push saline through the iv and we need to start a new iv.2: when we test the iv with a saline push we connect it to our power injector in ct and push isovue 370 at the rate of 2ml per second for normal contrast ct¿s and 4ml¿s per second for angio ct exams.This is when the contrast leaks out of the connection where the bd ext is connected to the insyte autoguard bc customer responded on (b)(6): could you please provide more details on what is meant by ¿it fails at times when we try to hand push saline¿? for example: when a patient comes to ct with one of these iv with the bd ext placed our ct tech will test the iv by attaching a 10ml saline syringe and pushing it through the iv.If the saline flows easily then they will connect it to the power injector that will push the contrast during the exam.There have been several instances where the ct tech is unable to push the saline through the iv.We believe this might be happening because the patient has had labs drawn and the vacutainer they use to connect to the bd ext moves the rubber piece and makes it so when our techs connect to the ext the saline doesn¿t flow through.Not sure that this is happening.What we do know is that (as stated above) when our ct tech tries to flush the iv with saline it doesn¿t flush.What type of failure is being experienced? answered above is the issue related to leakage or a flow problem? flow problem.
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.

• Brand Name: EXT EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• 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: 25385462
• Report Number: 1710034-2026-00596
• Device Sequence Number: 21009745
• Product Code: FPA
• UDI-Device Identifier: 00382903902200
• UDI-Public: (01)00382903902200
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K200439
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2026

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: 390220
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2026
• Supplement Date Received by Manufacturer: 06/05/2026
• Initial Report FDA Received Date: 06/03/2026
• Supplement Report FDA Received Date: 06/05/2026
• 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