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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: 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, images were provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 06/2025).H3 other text : device pending return.
Event or Problem Description
It was reported that during a transjugular intrahepatic portosystemic shunt procedure, the catheter of the kit allegedly broke and dislodged into patient.It was further reported that the physician had to snare the piece of the catheter that broke loose out of the patient.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: one liverty tips access set was received for evaluation.The device appeared to have residue throughout and was received without protective tubing.It appeared there was a complete circumferential break to the distal end of the steerable cannula with the detached piece returned.It appeared there was a bend to the distal end of the steerable cannula and to the proximal end of the detached steerable cannula piece.Under microscopic and x-ray examination dried blood and an unknown blue occlusion was discovered.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: d4 (expiry 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 of the kit allegedly had broken and dislodged into patient.It was further reported that the physician had to snare the piece of the catheter that broke loose out of the patient.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: one liverty tips access set was received for evaluation.The device appeared to have residue throughout and was received without protective tubing.It appeared there was a complete circumferential break to the distal end of the steerable cannula with the detached piece returned.It appeared there was a bend to the distal end of the steerable cannula and to the proximal end of the detached steerable cannula piece.Under microscopic and x-ray examination dried blood and an unknown blue occlusion was discovered.Two fluoroscopic images were provided which show a small, several centimeter-long piece of radiolucent tubular material (catheter) which is in discontinuity with a tips creation canula.This appears consistent with the complaint of the catheter tip from the liverty tips creation kit breaking off of the remainder of the catheter.The image provided shows the catheter fragment with a small space between the catheter and the needle exiting the canula.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: d4 (expiry 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 of the kit allegedly had broken and dislodged into patient.It was further reported that the physician had to snare the piece of the catheter that broke loose out of the patient.There was no reported patient injury.
Event or Problem Description
It was reported that during a transjugular intrahepatic portosystemic shunt procedure, the catheter of the kit allegedly had broken and dislodged into patient.It was further reported that the physician had to snare the piece of the catheter that broke loose out of the patient.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: one liverty tips access set was received for evaluation.The device appeared to have residue throughout and was received without protective tubing.It appeared there was a complete circumferential break to the distal end of the steerable cannula with the detached piece returned.It appeared there was a bend to the distal end of the steerable cannula and to the proximal end of the detached steerable cannula piece.Under microscopic and x-ray examination dried blood and an unknown blue occlusion was discovered.Two fluoroscopic images were provided which show a small, several centimeter-long piece of radiolucent tubular material (catheter) which is in discontinuity with a tips creation canula.This appears consistent with the complaint of the catheter tip from the liverty tips creation kit breaking off of the remainder of the catheter.The image provided shows the catheter fragment with a small space between the catheter and the needle exiting the canula.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 (expiry date: 06/2025), g3.H11: g1, g4.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 : see h10.

• 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: 17257123
• Report Number: 3014704491-2023-00310
• Device Sequence Number: 15431736
• Product Code: DYB
• UDI-Device Identifier: 00382903064663
• UDI-Public: (01)00382903064663
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,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: 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: 06/09/2023
• Supplement Date Received by Manufacturer: 07/28/2023; 11/09/2023; 01/23/2024
• Initial Report FDA Received Date: 07/05/2023
• Supplement Report FDA Received Date: 08/08/2023; 11/11/2023; 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
• Patient Sex: Unknown