MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 Vaccess CT Low-Profile Power-Injectable Implantable Port, ChronoFlex, 6F; Port & Catheter, Implanted, Subcutaneous, Intravascular

Catalog Number	7360001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Bradycardia (1751); Unspecified Infection (1930); Pneumonia (2011); Sepsis (2067); Tachycardia (2095); Respiratory Failure (2484)
Date of Event	03/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the physical device was not returned for evaluation.No medical records were provided for review.Therefore, the investigation is inconclusive for the reported infection as no objective evidence was provided for review.Furthermore, the clinical conditions alleged in the complaint cannot be confirmed.Based upon the available information labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.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 through litigation process that sometime after port placement, patient was diagnosed with infection.However, the current status of the patient was unknown.
Event or Problem Description
It was reported through the litigation process that, on (b)(6)2023, a patient underwent port placement via the right internal jugular vein for chemotherapy delivery.Approximately one year, two months and ten days later, on (b)(6) 2024, the patient was diagnosed with tachycardia, sinus bradycardia, sepsis and respiratory failure.Additionally, the patient was also diagnosed with staphylococcus salivarius and klebsiella pneumoniae infection, which was confirmed through blood culture.It was further reported that the patient eventually expired on the same day and the cause of death was reported as septic infection.
Additional Manufacturer Narrative
H11: additional information was identified in the medical record.Based on the identified information, the patient had eventually expired due to septic infection.Hence, the file was reassessed for reportability and determined to be reportable as death.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.The investigation of the reported event is currently underway.B1, b2, b3, b5, g3, h1, h6 (patient, 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: Vaccess CT Low-Profile Power-Injectable Implantable Port, ChronoFlex, 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: 21948803
• Report Number: 3006260740-2025-02779
• Device Sequence Number: 8691701
• Product Code: LJT
• UDI-Device Identifier: 00801741027444
• UDI-Public: (01)00801741027444(17)240531(10)REGX1872
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K072549
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2026

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: 05/31/2024
• Device Catalogue Number: 7360001
• Device Lot Number: REGX1872
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2025
• Supplement Date Received by Manufacturer: 09/18/2026
• Initial Report FDA Received Date: 05/02/2025
• Supplement Report FDA Received Date: 09/25/2026
• 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; Death
• Patient Age: 54 YR
• Patient Sex: Male