MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPORT CLEARVUE ISP IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 1608062

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

Patient Problems Unspecified Infection (1930); Sepsis (2067); Fungal Infection (2419)

Event Date 03/29/2023

Event Type  Injury  

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: the device was not returned for evaluation.Medical records were not provided.Therefore, the investigation is inconclusive for the reported adverse event as no objective evidence was provided for review.Furthermore, the clinical conditions alleged in the complaint cannot be confirmed.A definitive root cause could not be determined based upon the available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.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.H3 other text : device not returned.

Event Description

It was reported through the litigation process that sometime post a port placement, the patient allegedly experienced unspecified infection.It was further reported that the patient allegedly developed with sepsis as a result of the defective infected port.The current status of the patient is unknown.

Manufacturer Narrative

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 were provided.The medical record states that bard implanted port was placed to a patient diagnosed for bladder cancer accessed by long term central venous level.The port implanting procedure was taken place by port placing at the port packer underneath the skin at upper chest and the catheter was tunneled subcutaneously to the venous access site.The port and catheter were placed and confirmed by the fluoroscopic imaging.Approximately after eight months later the patient was admitted to emergency room with the complaint of fever prolonged nearly a week.The patient had also had a back pain and a stent at a kidney which is been removed, the patient has also diagnosed with urinary tract infection without hematuria.Computed tomography taken for abdominal pain, and it was also shows the right sided hydroureteronephrosis with removal of prior ureteral stent.Patient has admitted to hospital for sepsis, candida glabrata fungemia, hypokalemia, urinary tract infection.Two days later a x-ray of chest showed the right internal jugular port-a-cath in situ, tip terminates in the region of the svc.On the next day patient¿s blood culture shows candida glabra grew on blood culture and esbl e.Coli on urine culture.Furthermore, the infectious disease consulted and considered for possible infected right subclavian port-a-cath.Removal procedure of port was recommend and x-ray shows the port and catheter was unchanged from its position, after the port been removed patient aspirated after given medications developed acute hypoxic respiratory failure intubated on mechanical ventilation transferred to the intensive care unit for further care.Further the patient underwent medi-port removal, and it was proceeding with an incision made at the level of soft tissue the mediport was not to be embolized and removed without any difficulty and the incision site was closed.Finally, the patient was discharged and may transition to high dose fluconazole or alternative antifungal options such as voriconazole to finish the designated duration of therapy.Therefore, the investigation is inconclusive as no objective evidence for the reported deficiency with the port in the submitted medical record review.Additionally, it can be confirmed that the patient experienced fungal infection, sepsis.However, the relationship to the port is unknown.Furthermore, the clinical condition 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.(expiry date: 05/2023), 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 Description

It was reported through the litigation process that eight months and twenty four days post a port placement via the right internal jugular, the patient allegedly experienced candida glabrata fungemia.It was further reported that the patient allegedly developed with sepsis as a result of the defective infected port.Reportedly, antifungal medications were provided for treatment and the infected port was removed.The current status of the patient is unknown.

• Brand Name: POWERPORT CLEARVUE ISP IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 8F
• 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: 18872724
• MDR Text Key: 337291338
• Report Number: 3006260740-2024-01012
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741026430
• UDI-Public: (01)00801741026430
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/21/2024

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: 1608062
• Device Lot Number: REGR4498
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/16/2024
• Initial Date FDA Received: 03/11/2024
• Supplement Dates Manufacturer Received: 03/19/2024
• Supplement Dates FDA Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2022
• 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; Life Threatening
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Race: White