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

Catalog Number	390220
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2026
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 the ext had connection issues.Issue: this bd ext set does not lock when twisting the swivel locking piece.Of this lot, 6 of them were tested and all failed.Once twisted it will automatically partially reverse twist leaving the iv open for blood loss and contamination.Event date: 2/4/2026 was there injury? no.
Event or Problem Description
Additional information 2/23/2026: what was the product that the extension set was attempted to be connected to? they are being connected directly to bd insyte autoguard ivs was any leakage observed? yes, when attempting to screw the extension set onto the iv, it wouldn¿t grab hold, or lock in, so when the piece that you twist was released it would roll back and come undone, leaving an open iv with blood and fluid leakage.
Additional Manufacturer Narrative
Additional Manufacturer Narrative
The complaint that the ext extension set does not lock when twisting the luer locking collar could not be confirmed from the photograph and ext extension sets that were provided for investigation.Sixty ext extension sets were received in sealed unit packaging.Six units were received in unsealed unit packages.A functional test of both the sealed units and unsealed units revealed no leaks or untwisting of the luer locking collar when it was attached to a female luer adapter.There were no other similar complaints from the implicated lot.Although the returned samples and manufacturing records do not support the complainant¿s description of the reported event, the complaint has been documented and will continue to be monitored as part of ongoing efforts to identify potential manufacturing related issues.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Complaints received about 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 data collected for identification of emerging trends.
Event or Problem Description
No new information.

• 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): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city UT 84116
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 24406100
• Report Number: 1710034-2026-00174
• Device Sequence Number: 10113470
• Product Code: FPA
• UDI-Device Identifier: 00382903902200
• UDI-Public: (01)00382903902200(17)280831(10)REKW0408
• 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,Followup
• Report Date (Section B): 03/19/2026

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: REKW0408
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2026
• Supplement Date Received by Manufacturer: Not provided; 03/19/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 03/02/2026; 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown