MAUDE Adverse Event Report: C.R. Bard, Inc. (BASD) -3006260740 Vaccess CT Power-Injectable Implantable Port, Silicone, 9.6F; Port & Catheter, Implanted, Subcutaneous, Intravascular

Catalog Number	7496000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cellulitis (1768); Unspecified Infection (1930); Thromboembolism (2654)
Date of Event	05/22/2024
Type of Reportable Event	Death
Event or Problem Description
A patient underwent an port placement procedure using bd implanted port.Reportedly, the patient's condition began to improve in 2026, and the family requested removal of the port.According to the family, the request for removal was declined, and the patient later developed an infection, stated that puss was coming out from all over his body.The patient subsequently expired as a result of the infection.
Event or Problem Description
It was reported that a patient had a vaccess ct power injectable implantable port placed on (b)(6) 2021, at the cavoatrial junction for the treatment of stage iv pancreatic cancer.Reportedly, the patient's condition began to improve in 2026, and the family requested removal of the port.Per the family, the request for removal was declined.On (b)(6) 2024, the port site was noted to be red and painful.The patient had also developed swelling in the leg and chest.He was hospitalized and discharged on antibiotics; however, his condition did not improve.After some time, the patient was diagnosed with lower extremity cellulitis, anasarca, paraneoplastic syndrome, hyponatremia, sepsis, and deep vein thrombosis (dvt) requiring placement of an ivc filter.The patient subsequently expired, and his death was attributed to terminal pancreatic cancer with secondary contributing factors of sepsis and hyponatremia.
Additional Manufacturer Narrative
H11: date of death for this patient was not provided, date of death updated as (b)(6) for the mdr submission requirement.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.Section a through f: the information provide 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: as the lot number for the device was provided, a review of the device history records was performed.The device has been returned to the manufacturer for evaluation.However, photos of the infection in the patient were provided for review.The investigation of the reported event is currently underway.B2 (date of death), b3, b5, d1, d4 (medical device catalog #, medical device lot #, medical device expiration date, (unique identifier (udi) #)), d6a, g3, g4, h6 (patient, component, method, result, conclusion).Section a through f: the information provide 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: Vaccess CT Power-Injectable Implantable Port, Silicone, 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: michael gaffney ; 800 w. rio salado pkwy; tempe, AZ 85281 ; +1(480)303-2689
• MDR Report Key: 50207864
• Report Number: 3006260740-2026-05620
• Device Sequence Number: 16036656
• Product Code: LJT
• UDI-Device Identifier: 00801741027482
• UDI-Public: (01)00801741027482(11)201211(17)220831(10)REEY1193
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K063377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: 7496000
• Device Lot Number: REEY1193
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2026
• Supplement Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 08/11/2026
• Supplement Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/11/2020
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 58 YR
• Patient Sex: Male