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
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Unspecified Infection (1930); Sepsis (2067)
Date of Event	07/05/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: as the lot number for the device was not provided, a review of the device history records could not be 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.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 post a port placement, the patient allegedly developed with infection.However, the current status of the patient was unknown.
Additional Manufacturer Narrative
H11: 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.B3, b5, d4 (medical device lot #, unique identifier (udi) #), g3, 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.
Event or Problem Description
It was reported through the litigation process that, on (b)(6) , 2010, a patient underwent port placement via the right internal jugular vein for venous access related to porphyria.Approximately three years, four months and seventeen days later, on (b)(6) , 2013, the patient was diagnosed with staphylococcus bacterial infection, which was confirmed through blood culture.Subsequently, on (b)(6) , 2013, the port was removed due to sepsis.However, the current status of the patient remains unknown.
Event or Problem Description
It was reported through the litigation process that, on (b)(6)2010, a patient underwent port placement via the right internal jugular vein for venous access related to porphyria.Approximately three years, four months and seventeen days later, on (b)(6)2013, the patient was diagnosed with staphylococcus bacterial infection, which was confirmed through blood culture.Subsequently, on (b)(6)2013, the port was removed due to sepsis.However, the current status of the patient remains unknown.
Additional Manufacturer Narrative
H11: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this lot.Investigation summary: although the physical device was not returned for evaluation, a medical record was provided for review.Medical record alleges that, a powerport ti full size implantable port was implanted in a patient via the right internal jugular vein for venous access related to porphyria.Approximately, three years, four months and seventeen days later blood culture results confirmed staphylococcus infection.Subsequently, the port was removed on next day due to sepsis.Therefore, it can be confirmed that the patient had staphylococcus infection and sepsis.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.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: TI POWERPORT W/ ATTACH 8 FR CHRONO, INTER W/O PLUG
• 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: 20731867
• Report Number: 3006260740-2024-06789
• Device Sequence Number: 15688734
• Product Code: LJT
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K060812
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/02/2026

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 Catalogue Number: 1708001
• Device Lot Number: RETL0505
• 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: 10/24/2024
• Supplement Date Received by Manufacturer: 04/10/2026; 06/02/2026
• Initial Report FDA Received Date: 11/20/2024
• Supplement Report FDA Received Date: 04/28/2026; 06/15/2026
• 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
• Patient Age: 48 YR
• Patient Sex: Male