MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 TITANIUM LOW-PROFILE IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number	0606150
Medical Device Problem Codes	Fluid/Blood Leak (1250); Fracture (1260); Material Separation (1562); Deformation Due to Compressive Stress (2889); Naturally Worn (2988); Migration (4003)
Health Effect - Clinical Codes	Neck Pain (2433); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: as the lot number for the device was not provided, a review of the device history records could not be performed.The device has been returned to the manufacturer for evaluation.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) 2022, a patient underwent a port placement procedure via the right internal jugular vein with the port body positioned on the right anterior chest for chemotherapy administration using titanium low-profile implantable port, groshong single-lumen, 8f.Chemotherapy was completed, and monthly flushing continued for maintenance.Post the procedure on (b)(6) 2025, an x-ray revealed a fractured catheter, with the catheter tip confirmed to have migrated into the heart.The current status of the patient is unknown.
Event or Problem Description
On (b)(6) , 2022, a patient underwent a port placement procedure via the right internal jugular vein with the port body positioned on the right anterior chest for chemotherapy administration using titanium low-profile implantable port, groshong single-lumen, 8f.Chemotherapy was completed, and monthly flushing continued for maintenance.Post the procedure on (b)(6) , 2025, the patient reported neck pain during flushing, leading to a scheduled cv port removal on (b)(6) , 2025.Reportedly, on (b)(6) , 2025, an x-ray revealed a fractured catheter, with the catheter tip confirmed to have migrated into the heart.The current status of the patient is unknown.
Additional Manufacturer Narrative
H11: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one titanium implantable port attached to a groshong catheter in two segments was returned for evaluation.Gross visual, microscopic, tactile and functional evaluations were performed.A kink was noted on the distal portion of the attached catheter.A complete circumferential break was noted on the distal end of the attached catheter that was elliptical in shape.A complete circumferential break was noted on the proximal end of the distal catheter segment that was elliptical in shape.The edges of the complete circumferential break on the distal end of the attached catheter were noted to be uneven.The surface was noted to be granular in one region and round/smooth throughout the other region.The edges of the complete circumferential break on the proximal end of the distal catheter segment were noted to be uneven.The surface was noted to be granular in one region and round/smooth throughout the other region.The investigation is confirmed for the reported catheter fracture, material separation, fluid leak and identified catheter wear and deformation issues.However, the investigation is inconclusive for the reported migration issue as this cannot be verified from the returned physical sample.The identified break is typical of flexural fatigue, which is due to the repetitive, cyclic kinking of the catheter.Such kinking may have physiological, placement, usage or mechanical contributing factors.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.B5, g3, h6 (patient, device, component, method, result, conclusion) 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.

• Brand Name: TITANIUM LOW-PROFILE IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 8F
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 23836354
• Report Number: 3006260740-2025-09795
• Device Sequence Number: 9030350
• Product Code: LJT
• UDI-Device Identifier: 00801741026058
• UDI-Public: (01)00801741026058
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K050310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2026

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 Catalogue Number: 0606150
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2025
• Supplement Date Received by Manufacturer: 05/19/2026
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 05/20/2026
• 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: Unknown