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 Fungal Infection (2419)

Event Date 10/18/2023

Event Type  Injury  

Manufacturer Narrative

H10: as the lot number for the device was provided, a review of the device history record is currently being 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.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.

Event Description

It was reported through the litigation process that sometime post a port placement, the patient allegedly experienced candidemia infection.Reportedly, the patient underwent surgery to remove the defective device and to correct the complications.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: 18117738
• MDR Text Key: 327867242
• Report Number: 3006260740-2023-05140
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/24/2023

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: 10/18/2023
• Initial Date FDA Received: 11/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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