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

Catalog Number	306466
Medical Device Problem Codes	Device Contamination with Chemical or Other Material (2944); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, a patient underwent a transjugular intrahepatic portosystemic shunt (tips) procedure using the liverty tips access set.Prior to the procedure, it was reported that the foreign matter was found inside the puncture kit packaging upon opening.The procedure was completed using another device.There was no patient contact.
Additional Manufacturer Narrative
H11: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has not returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.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
On (b)(6) 2025, a patient underwent a transjugular intrahepatic portosystemic shunt procedure using the liverty tips access set.Prior to the procedure, it was reported that the foreign matter was found inside the puncture kit packaging upon opening.The procedure was completed using another device.There was no patient contact.
Additional Manufacturer Narrative
H11: manufacturing review: regarding the reported incident, the factory conducted an equipment history review for batch number 2319120.No abnormalities were found during production of this batch.Investigation summary: received one returned sample.The unit packaging has been opened, but the product has not been used.Upon inspecting the product¿s appearance, a black, movable, fiber-like foreign object approximately 3 mm in length was found.Conducted appearance inspection for the same batch retained sample, no fm found.It is possible that during the production process, fiber-like foreign matter from the environment was adsorbed onto the packaging bag.Employees have been trained to pay attention to such foreign object defects during packaging.This is the first complaint related to foreign matter since the product was launched.The factory has already taken corresponding measures and will continue to monitor the trend of such complaint defects.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.G3, h6 (device, method, result, conclusion).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.

• 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: 23861710
• Report Number: 3002601200-2025-00133
• Device Sequence Number: 15804996
• Product Code: DYB
• UDI-Device Identifier: 00382903064663
• UDI-Public: (01)00382903064663(17)251128(10)2319120
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K221440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2026

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 Expiration Date: 11/28/2025
• Device Catalogue Number: 306466
• Device Lot Number: 2319120
• 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: 11/27/2025
• Supplement Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 02/16/2026
• 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