MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU LIVERTY TIPS ACCESS SET; INTRODUCER, CATHETER

Catalog Number	306466
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, a patient underwent a procedure using trans jugular liver access set.During the procedure, the adjustable tip of the device fractured during cannula rotation prior to tips puncture.This required delicately removing the fractured cannula and using a new kit.There was no reported patient injury.
Additional Manufacturer Narrative
H11: the site legal name (fda) for the liverty tips access set product was selected as (b)(6).Due to system limitations.The correct site legal name (fda) for the liverty tips access set is (b)(6).As the lot number for the device was not provided, a review of the device history records could not be performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.Section a through f ¿ the information provide by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
On (b)(6) 2025, a patient underwent a procedure using trans jugular liver access set.During the procedure.The adjustable tip of the device fractured during cannula rotation prior to tips puncture.This required delicately removing the fractured cannula and using a new kit.There was no reported patient injury.
Additional Manufacturer Narrative
H11: the site legal name (fda) for the liverty tips access set product was selected as bard peripheral vascular, inc, - tempe, az/85281 due to system limitations.The correct site legal name (fda) for the liverty tips access set is becton dickinson medical devices co., ltd.Suzhou - suzhou, china / 215126.Manufacturing review: the device history record was not requested since the provided lot numbers was unknown.Investigation summary: one steerable cannula was received for evaluation.Product packaging and label were not returned.A partial circumferential break was observed on the distal portion of the steering cannula.No other anomalies were observed.Upon inspecting the steering cannula knob, the black bar on the knob was aligned to the top portion of the arrow base plate.The black bar on the knob was aligned to the top portion of the arrow base plate; it is possible that the rotation angle exceeded 75°.Excessive rotation combined with high liver tissue resistance during use may lead to steerable cannula breakage.Therefore, the investigation is confirmed for the reported fracture issue.A definitive root cause could not be determined based on the available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.G3, h6 (result, conclusion).Section a through f: the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• Brand Name: LIVERTY TIPS ACCESS SET
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU; no.1 liangpu street; suzhou industrial park; suzhou 21512 6; CH 215126
• Manufacturer (Section G): BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU; no.1 liangpu street; suzhou industrial park; suzhou 21512 6; CH 215126
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 23628887
• Report Number: 2020394-2025-01926
• Device Sequence Number: 21177628
• Product Code: DYB
• UDI-Device Identifier: 00382903064663
• UDI-Public: (01)00382903064663
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K221440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2026

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: 306466
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2025
• Supplement Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Race: White