MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 TI POWERPORT W/ ATTACH 8 FR CHRONO, INTER W/O PLUG; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 1708001

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bacterial Infection (1735)

Event Date 11/07/2022

Event Type  Injury  

Manufacturer Narrative

H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the device was not returned for evaluation.Medical records provided and reviewed.Approximately four months and twenty-nine days post port placement, port removal was indicated due to bacteremia.Successful removal of previously placed right internal jugular central venous infusion port.There were no overt signs of port infection.Port catheter tip cut and sent for culture.Therefore, the investigation is inconclusive for the reported adverse event as no objective evidence has been provided to confirm any alleged deficiency to the port.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.H10: d4 (expiration date: 04/2023).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.H3 other text: device not returned.

Event Description

It was reported through litigation process that four months and twenty-nine days post a port placement the port was allegedly infected.However, the current status of the patient is unknown.

• Brand Name: TI POWERPORT W/ ATTACH 8 FR CHRONO, INTER W/O PLUG
• Type of Device: 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: 18919621
• MDR Text Key: 337844500
• Report Number: 3006260740-2024-01139
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741026584
• UDI-Public: (01)00801741026584
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060812
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/29/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 1708001
• Device Lot Number: REGP3225
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/28/2024
• Initial Date FDA Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male