MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 TITANIUM IMPLANTABLE PORT, HICKMAN SINGLE-LUMEN, 9.6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number	0602230
Medical Device Problem Codes	Fracture (1260); Device Appears to Trigger Rejection (1524); Material Separation (1562); Migration (4003)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported through the litigation process that sometime post a port placement, the port catheter was allegedly fractured.There was no reported patient injury.
Additional Manufacturer Narrative
H10: as the lot number for the device was not provided, a review of the device history records could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.H11: 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
It was reported through litigation process that, on (b)(6) 2022, a patient underwent a port implantation via the left subclavian vein for the treatment of colon cancer.Approximately five months and eighteen days later, on (b)(6) 2023, the catheter had allegedly fractured with migration of a fragment to the right atrium, which was confirmed by a chest x ray.Subsequently, the patient underwent port and fragment removal on (b)(6) 2023.Additionally, a fibrin sheath formation was observed during the removal.However, the current status of the patient was unknown.
Additional Manufacturer Narrative
H11: additional information was identified in medical records, and the file was reassessed for reportability and determined to be reportable as serious injury.As the lot number for the device was not provided, a review of the device history records could not be performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.B1, b3, b5, g3, h1, h6 (patient, device, 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.
Additional Manufacturer Narrative
H11: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: the physical device was not returned for evaluation, medical record was provided for review.Medical record review: medical record alleges that, the patient underwent an implantable port placement procedure using a powerport for chemotherapy delivery as part of treatment of colon cancer.Chest x ray was ordered in the recovery to check position and pneumothorax.Five months and seventeen days later, the patient underwent a chest x ray, which revealed that the left chest port had fractured, with the distal portion of the catheter freely mobile.The fragment was noted to be positioned at the level of the superior vena cava and right atrium.Next day, the catheter fragment was removed through the sheath in the right groin.On the same day, blunt and sharp dissection were utilized to free the subcutaneous chest port from its fibrin sheath.The tube was secured and the port and tubing were removed from the patient.Therefore, the investigation is confirmed for the reported catheter fracture, material separation, migration of catheter and the fibrin sheath formed around the chest port.Based upon the available information, the definitive root cause is unknown.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.G3, h6 (method, result, conclusion).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 through litigation process that, on (b)(6) 2022, a patient underwent a port implantation via the left subclavian vein for the treatment of colon cancer.Approximately five months and eighteen days later, on (b)(6) 2023, the catheter had allegedly fractured with migration of a fragment to the right atrium, which was confirmed by a chest x ray.Subsequently, the patient underwent port and fragment removal on (b)(6) 2023.Additionally, a fibrin sheath formation was observed during the removal.However, the current status of the patient was unknown.

• Brand Name: TITANIUM IMPLANTABLE PORT, HICKMAN SINGLE-LUMEN, 9.6F
• 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: 20275860
• Report Number: 3006260740-2024-05394
• Device Sequence Number: 3393264
• Product Code: LJT
• UDI-Device Identifier: 00801741025563
• UDI-Public: (01)00801741025563
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K050310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/03/2026

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: 0602230
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2024
• Supplement Date Received by Manufacturer: 02/25/2026; 04/02/2026
• Initial Report FDA Received Date: 09/22/2024
• Supplement Report FDA Received Date: 03/26/2026; 04/08/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female