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

Model Number	306466
Medical Device Problem Codes	Break (1069); Fracture (1260); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.However, a photo was provided for review.The investigation of the reported event is currently underway.(expiry date: 01/2025).Device evaluated by mfr: device not returned.
Event or Problem Description
It was reported that during a transjugular intrahepatic portosystemic shunt procedure, the device allegedly had difficulty in tracking and seeing the needle through intracardiac echocardiography.It was further reported that the flex point of the needle allegedly broke and lost all push as well as puncture ability.The procedure was completed using another device.There was no reported patient injury.
Event or Problem Description
It was reported that during a transjugular intrahepatic portosystemic shunt procedure, the device allegedly had difficulty in tracking and seeing the needle through intracardiac echocardiography.It was further reported that the flex point of the needle allegedly broke and lost all push as well as puncture ability.The procedure was completed using another device.There was no reported patient injury.
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: the sample was not returned for evaluation.However, one photo was provided for evaluation.The photo shows the needle broke and fracture.The root cause could not be confirmed due to lack of detail information during use.Therefore, the investigation is inconclusive 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: d4 (expiry date: 01/2025), g3, h6 (method).H11: h6 (device, result, conclusion).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.H3 other text : device not returned.
Additional Manufacturer Narrative
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: the sample was not returned for evaluation.However, one photo was provided for evaluation.The photo shows the needle broke and fracture.The root cause could not be confirmed due to lack of detail information during use.Therefore, the investigation is inconclusive 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 device allegedly had difficulty in tracking and seeing the needle through intracardiac echocardiography.It was further reported that the flex point of the needle allegedly broke and lost all push as well as puncture ability.The procedure was completed using another device.There was no reported patient injury.

• 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: 16543754
• Report Number: 3014704491-2023-00051
• Device Sequence Number: 12375193
• Product Code: DYB
• UDI-Device Identifier: 00382903064663
• UDI-Public: (01)00382903064663
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 306466
• Device Catalogue Number: 306466
• Device Lot Number: 2006999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/14/2023
• Supplement Date Received by Manufacturer: 03/31/2023; 01/23/2024
• Initial Report FDA Received Date: 03/15/2023
• Supplement Report FDA Received Date: 04/16/2023; 01/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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