MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPORT DUO M.R.I. IMPLANTABLE PORT, CHRONOFLEX DUAL-LUMEN, 9.5F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 1829500

Device Problems Difficult to Flush (1251); Suction Problem (2170)

Patient Problems Bacterial Infection (1735); Sepsis (2067)

Event Date 04/19/2022

Event Type  Injury  

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 (expiration date: 03/2021) 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 litigation process that two years one month and twenty-two days post a port placement, the patient allegedly developed with bacterial infection and bacteremia.It was further reported that port was not functioning well, and patient developed with sepsis.Reportedly the infected port was removed.However, the current status of the patient is 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.Thirty-nine electronic photos were provided and reviewed.The first, second and twenty fifth photo shows the patient implant card in which patient and product information were verified.The third, fourth, fifth and sixth photo shows the port attached to the catheter tubing placed inside a container.Tissues were noted near to the port stem.The remaining photos shows the patient with unknown catheter implanted and relevant chat history with the healthcare provider.Medical records were provided and reviewed.Approximately two years, one month and twenty-two days post port placement, blood culture shows positive for coagulase negative staphylococcus epidermidis infection.Around one day later, patient admitted to the hospital for bacteremia, sepsis, and covid-19 infection.The patient tested positive for covid-19 and blood culture positive with coagulase negative staphylococcus from the port.Bacteremia with staphylococcus epidermis line related and was placed on vancomycin and was able to clear infection quickly and port was saved.Around seven days later, patient was discharged home in stable condition on iv antibiotics.Around eight days later, patient admitted to the hospital for sepsis.Patient presented with the complaints of cough, shortness of breath and fever.The patient port stopped working and noted to be the patient developed tachycardic, tachypneic and recommended to come to emergency department.The patient completed last dose of vancomycin and was started on cefepime and azithromycin.After extensive work-up it seemed symptoms were more likely from covid-19 waxing and waning due to immunosuppressed state.The patient was started on empiric antibiotic treatments.The patient was evaluated by interventional radiologist for port removal and recommended to be done as outpatient since it is non-urgent procedure.Around six days later, patient was stable and discharged home.Around seven days later, patient underwent port removal procedure for not working port and no longer needed and possible infection.The port was removed successfully.Around one day later, a computed tomography of chest, abdomen and pelvis showed redemonstration of diffuse multifocal infection with extensive bilateral ground glass opacities, appears slightly improved in the upper lobe and left lung base, perhaps slightly worsened in the right lower lobe.Interval removal of the infusion port catheter with residual air and trace hematoma in the left anterior chest wall.Therefore, the investigation is confirmed for the reported suction and difficult to flush issue based on medical records.Additionally, it can be confirmed that patient experienced bacterial infection post port placement.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.H10: b5, d4 (expiration date: 03/2021), g3, h6 (method) h11: b2, h6 (result, conclusion) 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.H3 other text : device not returned.

Event Description

It was reported through litigation process that two years, one month and twenty-two days post a port placement via the left internal jugular vein approach, the patient allegedly developed with bacterial infection with the culture test positive for coagulase negative staphylococcus epidermidis infection from the port.It was further reported that the patient was allegedly diagnosed with bacteremia and sepsis.It was also reported that the port was functioning well, and allegedly stopped working.Furthermore, the patient was treated with glycopeptide, cephalosporin and macrolide antibiotics.Reportedly the infected port was removed.However, the current status of the patient is unknown.

• Brand Name: POWERPORT DUO M.R.I. IMPLANTABLE PORT, CHRONOFLEX DUAL-LUMEN, 9.5F
• 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: 19072781
• MDR Text Key: 339737449
• Report Number: 3006260740-2024-01591
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741027185
• UDI-Public: (01)00801741027185
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090512
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/24/2024

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: 1829500
• Device Lot Number: REDV1413
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/26/2024
• Initial Date FDA Received: 04/09/2024
• Supplement Dates Manufacturer Received: 04/24/2024
• Supplement Dates FDA Received: 04/29/2024
• 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; Life Threatening
• Patient Age: 53 YR
• Patient Sex: Male