MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 TITANIUM LOW-PROFILE IMPLANTABLE PORT, BROVIAC SINGLE-LUMEN, 6.6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number	0602190
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Drug Resistant Bacterial Infection (4553); Bacteremia (4846)
Date of Event	01/17/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported through the litigation process that sometime post a port placement, the patient developed with unspecified infection.The current status of the patient is unknown.
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed, and this lot met all release criteria.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, 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.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: manufacturing review: the device history records have been reviewed, and this lot met all release criteria.Investigation summary: the physical device was not returned for evaluation.Medical records were provided for review.The medical records allege that the patient underwent explanation of an indwelling low profile port due to pain and discomfort, followed on the same day by implantation of a powerport for immunotherapy delivery via the right internal jugular vein under ultrasound and fluoroscopic guidance, with the catheter positioned at the cavoatrial junction and no procedural complications reported.Approximately two and a half months later, the patient presented with fevers and was diagnosed with methicillin resistant staphylococcus aureus (mrsa) bacteremia based on blood cultures, prompting surgical removal of the port and catheter, which were removed intact and sent for culture.Approximately ten months later, the patient was again documented to have bacteremia and an infected port a cath and underwent an additional port removal procedure, including excision of the port and catheter, irrigation of the pocket, and closure allowing for drainage.The patient tolerated the procedures without reported complication.Therefore, it can be confirmed that the patient had experienced bacterial infection, drug resistant bacterial infection and bacteremia.However, the relationship to the port is unknown.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.B3, b5, g3, h6 (patient, method, result).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) 2020, the patient underwent a port placement procedure using a powerport for immunotherapy delivery.Approximately two months and eighteen days later, on (b)(6) 2021, the patient was diagnosed with port catheter infection.It was further reported that the patient was diagnosed with mrsa infection and bacteremia.Subsequently on the same day, the port was removed.However, the current status of the patient was unknown.

• Brand Name: TITANIUM LOW-PROFILE IMPLANTABLE PORT, BROVIAC SINGLE-LUMEN, 6.6F
• 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: 22477702
• Report Number: 3006260740-2025-04726
• Device Sequence Number: 12900236
• Product Code: LJT
• UDI-Device Identifier: 00801741025549
• UDI-Public: (01)00801741025549(11)200423(17)241130(10)REEQ2755
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K050310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2024
• Device Catalogue Number: 0602190
• Device Lot Number: REEQ2755
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2025
• Supplement Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 07/11/2025
• Supplement Report FDA Received Date: 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/23/2020
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female