MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 IMPLANTED PORT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number	UNKNOWN IMPLANTED PORT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Sepsis (2067); Drug Resistant Bacterial Infection (4553)
Date of Event	10/11/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported through the litigation process that, on (b)(6) 2017, a patient underwent port implantation for an unknown medical condition.Approximately five months and eight days later, on (b)(6) 2017, the patient was diagnosed with methicillin resistant staphylococcus aureus (mrsa) bacterial infection.Approximately one day later, on (b)(6) 2017, the patient was also diagnosed with sepsis.Subsequently, the port was removed on (b)(6) 2017.However, the current status of the patient remains unknown.
Additional Manufacturer Narrative
H11: as the lot number for the device was not provided, a review of the device history records could not be performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.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.
Additional Manufacturer Narrative
H11: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: the physical device was not returned for evaluation, medical report was provided for review.Medical record alleges that, an unknown bard powerport was implanted in a patient.The patient was presented to hospital with fever and chills.Blood culture on the same day confirmed gram positive cocci.Subsequently, the patient was treated with broad spectrum antibiotic.Next day, the patient was consulted for sepsis.Therefore, it can be confirmed that the patient had gram positive cocci (mrsa) 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.G3, h6 (method, result, conclusion) 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 the litigation process that, on (b)(6) , 2017, a patient underwent port implantation for an unknown medical condition.Approximately five months and eight days later, on (b)(6) , 2017, the patient was diagnosed with methicillin resistant staphylococcus aureus (mrsa) bacterial infection.Approximately one day later, on (b)(6) , 2017, the patient was also diagnosed with sepsis.Subsequently, the port was removed on (b)(6).2017.However, the current status of the patient remains unknown.

• Brand Name: IMPLANTED PORT
• 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: 24738599
• Report Number: 3006260740-2026-02121
• Device Sequence Number: 19718586
• Product Code: LJT
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2026

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: UNKNOWN IMPLANTED PORT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2026
• Supplement Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 04/16/2026
• 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: 50 YR
• Patient Sex: Male