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

Catalog Number 1708160

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

Patient Problems Bacterial Infection (1735); Unspecified Infection (1930); Pain (1994); Sepsis (2067); Embolism/Embolus (4438)

Event Date 12/30/2021

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.Based on 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.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 some time post a port placement, the patient was allegedly diagnosed with infection and sepsis.The current status of the patient was unknown.

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 received and reviewed.The review states the bard single lumen implantable port was implemented into the patient for chemotherapy treatment for right breast cancer.The port was implemented at the left internal jugular vein with the help of ultrasound guidance and the tip of the catheter positioned at right atrium, the implanted port was coming into use immediately.Approximately after fifteen days, the patient was admitted with the complaint of generalized weakness, anorexia, cough and fever and concerned of infection as the patient under the chemotherapy.A chest x-ray was performed, and it was observed that the left sided chest wall port with distal catheter tip terminating at the cavoatrial junction.Patient¿s blood culture shows positive of mssa and to have a sustained bacteremia with septic emboli and started on empiric antibiotic with vancomycin and zosyn.Further computed tomography was performed and shows multiple are of nodularity ad some solid appearance within the left lung and some more ground glass like appearance similar like the right lungs.It was believed the source of mssa due to port for chemotherapy and it was consulted for port removal.Patient was suffered from pain around the port and pain in left shoulder.With orthopedic surgery the port was removed from the left shoulder.However, the patient had some slight erythema superior ad medial to the port site.It was reported that mild pain at the port site in which ice placed over the site of incision.Then the incision and port pocket were closed with no evidence of on infection at the site.If get infected it was consulted to open up the wound.The mri scan reveals minimal and no joint effusion which can be normal finding with a full thickness supraspinatus tear.The patient had full painless range of motion over the left shoulder joint and highly unlikely primary source of sepsis.No need for aspiration of the left shoulder and no acute operative intervention at this time.Then a computed tomography of chest shows the no central pulmonary embolism.Approximately after two days of port removal, the patient was recommended to internal medicine.However, the port site with some erythema/fluctuance, surgery thinks hematoma, however if repeat blood culture is growing staphylococcus aureus.On the next day blood culture shows the evidence of staphylococcus aureus.The physician able to express 30 ml of hemorrhagic pus from her left port site and patient underwent incision and drainage of abscess from the port pocket.Approximately after eight day the patient was discharged and after four days the patient had a complaint of vomiting, diarrhea and abdominal pain and further the patient was diagnosed with clostridium difficile and required oral vancomycin, iv flagyl as well as fidaxomicin for management of her diarrhea.Her diarrhea improved however and remains on her cefazolin.She continued on oral vancomycin for 7 days after that is completed to complete her treatment of clostridium difficile.Approximately after ten days the patient was discharged.Therefore, the investigation is inconclusive as no objective evidence for the the reported deficiency with the port in the submitted medical record review.Additionally, it can be confirmed that the patient experienced embolism, pain, bacterial infection, bacteremia and sepsis.However, the relationship to the port is unknown.Furthermore, the clinical condition alleged in the complaint cannot be confirmed.Based on 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: 10/2022), g2, g3, h6 (method).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 two weeks and two days post port placement via the left internal jugular vein, the patient allegedly experienced pain over the port site.It was further reported that the patient allegedly experienced bacterial infection and the cultures showed positive for methicillin-resistant staphylococcus aureus and found to have sustained bacteremia.Furthermore, the patient was diagnosed with sepsis and septic emboli.Reportedly, patient was treated with antibiotics and the infected port was removed.The current status of the patient was unknown.

• Brand Name: POWERPORT ISP IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, KIT, 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: 18674864
• MDR Text Key: 334948551
• Report Number: 3006260740-2024-00425
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741026676
• UDI-Public: (01)00801741026676
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072215
• 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: 03/16/2024

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: 1708160
• Device Lot Number: REFW3086
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/16/2024
• Initial Date FDA Received: 02/09/2024
• Supplement Dates Manufacturer Received: 03/11/2024
• Supplement Dates FDA Received: 03/25/2024
• 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
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic