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	04/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: 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.H10: as the lot number for the device was not provided, a review of the device history records could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.H11: 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 was undergoing a trans jugular intrahepatic portosystemic shunt procedure using liverty tips access set.It was reported that during the procedure, the needle allegedly did not aspirate.Additionally, the cannula allegedly shredded the catheter.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: the fda rn number for the mdr 2020394-2025-00644 was submitted as 2020394 due to system limitations.The correct fda rn number was 3002601200.H10: as the lot number for the device was not provided, a review of the device history records could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.H11: 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 was undergoing a trans jugular intrahepatic portosystemic shunt procedure using liverty tips access set.It was reported that during the procedure, the needle allegedly did not aspirate.Additionally, the cannula allegedly shredded the catheter.The procedure was completed using another device.There was no reported patient injury.
Event or Problem Description
On (b)(6) 2025, a patient was undergoing a trans jugular intrahepatic portosystemic shunt procedure using liverty tips access set.It was reported that during the procedure, the needle allegedly did not aspirate.Additionally, the cannula allegedly shredded the catheter.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H11: manufacturing review: as the lot number for the device was not provided, a review of the device history records could not be performed.Investigation summary: the sample was not returned to the manufacturer for inspection/evaluation.No photos were provided for review.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.G3, h6 (component, method, result) 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; 5 baiyu road; suzhou industrial park; jiangsu 21502 1; CH 215021
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 21937911
• Report Number: 2020394-2025-00644
• Device Sequence Number: 20184589
• Product Code: DYB
• UDI-Device Identifier: 00382903064663
• UDI-Public: (01)00382903064663
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/05/2025

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: 306466
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2025
• Supplement Date Received by Manufacturer: 05/01/2025; 11/05/2025
• Initial Report FDA Received Date: 04/30/2025
• Supplement Report FDA Received Date: 05/12/2025; 11/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Unknown