MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPORT IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 8F; 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); Sepsis (2067); Septic Shock (2068); Bacteremia (4846)
Date of Event	06/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported through litigation process that approximately one year, four months and twelve days post a port placement, for the treatment of lung cancer, the patient allegedly developed with bacteremia and bacterial infection.It was further reported that patient developed with sepsis and septic shock and treated with vasopressors.Reportedly, the infected port was removed.However, the current status of the patient is unknown.
Additional Manufacturer Narrative
H10: 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.H10: d4 (expiry date: 07/2022).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.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.The medical records allege the patient underwent port placement procedure for chemotherapy treatment for lung cancer.The port was successfully placed of right internal jugular central vein.The port was ready for immediate use.Around one year and five months later, the patient presented to hospital with the complaints of shortness of breath, fever and cough.Remained hypotensive despite normal saline bolus infusion.Infectious disease consulted for shortness of breath and bacteremia.Blood cultures showed gram positive cocci and advised to repeat blood cultures.The patient was diagnosed as severe sepsis with septic shock and required vasopressin and steroids.Started on norepinephrine infusion for sepsis and started on vancomycin and cefepime for healthcare associated pneumonia.The next day, the patient was on vancomycin and cefepime.The patient did have chemo port.Three days later, the patient underwent removal of subcutaneous port due to nidus for the infection.Using a scalpel an incision was made overlying the port.This was deepened down to the port with the scalpel.The port was dissected free of the surrounding capsule using scissors and blunt dissection.The port was removed from the catheter and the catheter was removed and placed in a specimen cup for culture.The port was grasped with a hemostat and lifted out of the incision and all the adhesions and capsule cleared away from the port.This was also passed off and placed in the cup for culture.Per the medical record review, it was confirmed the patient had bacterial infection, bacteremia, sepsis and septic shock.However, the relationship between the port and the alleged adverse event is unknown, and there was no device malfunction that was reported or occurred.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 (expiry date: 07/2022), g3, h6 (method).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 one year, four months and twelve days post a port placement for the treatment of lung cancer, the patient allegedly developed with bacteremia and bacterial infection.It was further reported that patient developed with sepsis and septic shock and treated with vasopressors.Reportedly, the infected port was removed.However, the current status of the patient is unknown.

• Brand Name: POWERPORT IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 8F
• 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: 19700488
• Report Number: 3006260740-2024-03556
• Device Sequence Number: 11666644
• Product Code: LJT
• UDI-Device Identifier: 00801741026584
• UDI-Public: (01)00801741026584
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K060812
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 1708001
• Device Lot Number: REEW3199
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2024
• Supplement Date Received by Manufacturer: 07/26/2024
• Initial Report FDA Received Date: 07/09/2024
• Supplement Report FDA Received Date: 08/08/2024
• 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: 72 YR
• Patient Sex: Female
• Patient Weight: 73 KG