MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 VACCESS CT POWER-INJECTABLE IMPLANTABLE PORT, CHRONOFLEX, 6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number	7460000
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Device Tipped Over (2589)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed, and this lot met all release criteria.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately, two months seventeen days post port placement, patient underwent port check and venogram procedure for port dysfunction.The port was seen to be slightly rotated in the soft tissues, with port reservoir facing slightly left anterior oblique relative to the skin surface.With proper angulation, the port was accessed.Venogram was performed, showing brisk flow through the port into the right atrium.No evidence of obstruction or fibrin sheath.Approximately one year three months twenty days later, contrast study was done and showing a fibrin sheath at the tip of the catheter.Because of this, the port was exchanged with new port.Therefore, the investigation is confirmed for the reported port rotation and device appear to trigger reaction issues.Furthermore, clinical conditions alleged in the complaint can be confirmed.Based upon the available information, the definitive root cause is unknown.Labelling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.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.
Event or Problem Description
It was reported through the litigation process that two months two weeks and three days later port placement procedure, the port rotated and fibrin sheath formation around the tip of the catheter.Reportedly, the port was removed, and new port has been implanted.The current status of the patient is unknown.

• Brand Name: VACCESS CT 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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 22901610
• Report Number: 3006260740-2025-06281
• Device Sequence Number: 18147109
• Product Code: LJT
• UDI-Device Identifier: 00801741027468
• UDI-Public: (01)00801741027468(11)230119(17)240831(10)REGY2371
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K063377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/19/2025

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 Expiration Date: 08/31/2024
• Device Catalogue Number: 7460000
• Device Lot Number: REGY2371
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2025
• Initial Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/19/2023
• 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: 19 YR
• Patient Sex: Female