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

Catalog Number	306466
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hyperbilirubinemia (1903)
Date of Event	10/21/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records will 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.H10: d4 (expiration date: 07/2026).H11: 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.
Event or Problem Description
It was reported through results of a clinical trial that approximately three weeks and three days post index procedure using a liverty tips access set through right jugular vein, the subject had an adverse event of hypokalemia and hyperbilirubinemia.It was further reported that the adverse event relationship was possibly related to the tips access set and tips stent graft and causally related to tips index procedure.Reportedly, the subject was treated with potassium chloride and recovering.The current status of the subject was unknown.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the physical sample was not returned for evaluation.No photos were provided for review.Therefore, it was not able to confirm the indicated failure mode.No related defect complaint from same lot, cannot identify it related with production.Not found any abnormal for the assembly & sterilization process and production line & the production environment initial bacterial contamination monitor not found any abnormal.A definitive root cause could not be determined based upon the available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H11: 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.
Event or Problem Description
It was reported through results of a clinical trial that three weeks and three days post an index procedure using a liverty tips access set through right jugular vein, the subject allegedly had an adverse event of hypokalemia and hyperbilirubinemia.It was further reported that the adverse event relationship was possibly related to the tips access set and tips stent graft and causally related to tips index procedure.Reportedly, the subject was treated with potassium chloride and recovering.The current status of the subject was unknown.
Additional Manufacturer Narrative
H10: the fda rn number for the initial mdr was inadvertently submitted as (b)(4).The correct fda rn number was (b)(4).H10: manufacturing review: a manufacturing review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the physical sample was not returned for evaluation.No photos were provided for review.Therefore, it was not able to confirm the indicated failure mode.No related defect complaint from same lot, cannot identify it related with production.Not found any abnormal for the assembly & sterilization process and production line & the production environment initial bacterial contamination monitor not found any abnormal.A definitive root cause could not be determined based upon the available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: g3, h6 (component).H11: 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.
Event or Problem Description
It was reported through results of a clinical trial that three weeks and three days post an index procedure using a liverty tips access set through right jugular vein, the subject allegedly had an adverse event of hypokalemia and hyperbilirubinemia.It was further reported that the adverse event relationship was possibly related to the tips access set and tips stent graft and causally related to tips index procedure.Reportedly, the subject was treated with potassium chloride and recovering.The current status of the subject was unknown.

• Brand Name: LIVERTY TIPS ACCESS SET
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL DEVICES CO. LTD. SUZHOU; 5 baiyu road; suzhou industrial park; jiangsu 21502 1; CH 215021
• 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: 20721512
• Report Number: 2020394-2024-01711
• Device Sequence Number: 17781024
• Product Code: DYB
• UDI-Device Identifier: 00382903064663
• UDI-Public: (01)00382903064663(17)260704(10)3153420
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/14/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/04/2026
• Device Catalogue Number: 306466
• Device Lot Number: 3153420
• 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: 10/22/2024
• Supplement Date Received by Manufacturer: 12/17/2024; 05/12/2025
• Initial Report FDA Received Date: 11/19/2024
• Supplement Report FDA Received Date: 01/10/2025; 05/22/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 80 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White