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

Model Number	306466
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/03/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.However, an image was provided for review.The investigation of the reported event is currently underway.(expiry date: 06/2025).Device pending return.
Event or Problem Description
It was reported that during a transjugular intrahepatic portosystemic shunt procedure, the catheter allegedly sheared when tried to push the needle.It was further reported that there was about an inch of the catheter left in the patient.Further it took 3 hours to remove the segment from the patient body.The procedure was completed using another device.The current status of the patient is unknown.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records were reviewed and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one liverty tips access set (kit components: 18g puncture needle and 5fr catheter) was received for evaluation.It appeared there was a complete circumferential break to the distal tip of both the catheter and needle with the detached pieces returned.The detached segment of the needle was observed to have a bend and was inserted into the distal end of the catheter.It appeared there was a kink to the catheter and multiple bends throughout the needle.Therefore, the investigation is confirmed for the reported issue.A definitive root cause could not be determined based upon the available information.Labeling review: a review of product labeling documentation (instruction for use, unit label, case label and carton label) did not find any product labeling inadequacy.The information provided by bd represents all of 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 that during a transjugular intrahepatic portosystemic shunt procedure, the catheter allegedly sheared when tried to push the needle.It was further reported that there was about an inch of the catheter left in the patient.Further it took three hours to remove the segment from the patient body.The procedure was completed using another device.The current status of the patient is unknown.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records were reviewed and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one liverty tips access set (kit components: 18g puncture needle and 5fr catheter) was received for evaluation.It appeared there was a complete circumferential break to the distal tip of both the catheter and needle with the detached pieces returned.The detached segment of the needle was observed to have a bend and was inserted into the distal end of the catheter.It appeared there was a kink to the catheter and multiple bends throughout the needle.Therefore, the investigation is confirmed for the reported issue.A definitive root cause could not be determined based upon the available information.Labeling review: a review of product labeling documentation (instruction for use, unit label, case label and carton label) did not find any product labeling inadequacy.H10: d3, d4 (expiration date: 06/2025).H11: section a through f - the information provided by bd represents all of 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 that during a transjugular intrahepatic portosystemic shunt procedure, the catheter allegedly sheared when tried to push the needle.It was further reported that there was about an inch of the catheter left in the patient.Further it took three hours to remove the segment from the patient body.The procedure was completed using another device.The current status of the patient is 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; 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: 16654467
• Report Number: 3014704491-2023-00084
• Device Sequence Number: 6521688
• Product Code: DYB
• UDI-Device Identifier: 00382903064663
• UDI-Public: (01)00382903064663
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 01/25/2024

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 Model Number: 306466
• Device Catalogue Number: 306466
• Device Lot Number: 2158998
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/03/2023
• Supplement Date Received by Manufacturer: 07/11/2023; 01/23/2024
• Initial Report FDA Received Date: 03/31/2023
• Supplement Report FDA Received Date: 07/14/2023; 01/26/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male