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

Catalog Number 1808001

Device Problems Fracture (1260); Expulsion (2933)

Patient Problems Cellulitis (1768); Chest Pain (1776); Unspecified Infection (1930)

Event Date 12/18/2023

Event Type  Injury  

Manufacturer Narrative

H10: as the lot number for the device was not provided, a review of the device history records could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.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 sometime post a port placement, the port allegedly fractured, and the port eroded.It was further reported that patient allegedly developed infection and alleged having chest pain.However, the current status of the patient is unknown.

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 provided and reviewed.Approximately three months and twenty-five days post first port placement, the patient presented with redness tenderness in the anterior chest wall surrounding the port.The patient had low grade fever but no chills.Around five days later, removal of right subclavian port was planned.Pus around the port in the left chest was noted.Around twenty-five days later, placement of right subclavian bard power port was done.Approximately one year and seven months post second port placement, the patient diagnosed with bacteremia and possible endocarditis and so the port removal was planned and completed.Around two months and three days later, placement of right subclavian bard power port was completed successfully.Approximately three years and six months post third port placement, the patient presented with open wound at powerport and presented with drainage from her powerport right chest and also noted to have difficult access.Around eight days later, removal of existing port and new mri powerport placement was planned and completed successfully.Approximately two years and six months post fourth port placement, x ray port revealed that the port was malpositioned.Around seven days later, the removal of right subclavian vein powerport was planned and placement of left internal jugular vein bard powerport was done successfully.Approximately three years and two months post fifth port placement, x ray of port revealed malfunctioned left sided chest port demonstrating extravasation at the level of the jugular vein.Around eleven days later, placement of left subclavian bard powerport and removal of left internal jugular vein powerport was planned.New port was placed successfully.The patient was taken in stable condition.Therefore, the investigation is kept as inconclusive for the reported fracture and expulsion as no objective evidence was provided for review.Furthermore, the clinical conditions 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.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 the litigation process that sometime post a port placement, the port allegedly fractured and the port was eroded.It was further reported that the patient allegedly developed an unspecified infection and alleged having chest pain.Reportedly, the port was removed and replaced.The current status of the patient is unknown.

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 provided and reviewed.Approximately three months and twenty-five days post first port placement, the patient presented with redness tenderness in the anterior chest wall surrounding the port.The patient had low grade fever but no chills.Around five days later, removal of right subclavian port was planned.Pus around the port in the left chest was noted.Around twenty-five days later, placement of right subclavian bard power port was done.Approximately one year and seven months post second port placement, the patient diagnosed with bacteremia and possible endocarditis and so the port removal was planned and completed.Around two months and three days later, placement of right subclavian bard power port was completed successfully.Approximately three years and six months post third port placement, the patient presented with open wound at powerport and presented with drainage from her powerport right chest and also noted to have difficult access.Around eight days later, removal of existing port and new mri powerport placement was planned and completed successfully.Approximately two years and six months post fourth port placement, x ray port revealed that the port was malpositioned.Around seven days later, the removal of right subclavian vein powerport was planned and placement of left internal jugular vein bard powerport was done successfully.Approximately three years and two months post fifth port placement, x ray of port revealed malfunctioned left sided chest port demonstrating extravasation at the level of the jugular vein.Around eleven days later, placement of left subclavian bard powerport and removal of left internal jugular vein powerport was planned.New port was placed successfully.The patient was taken in stable condition.Therefore, the investigation is kept as inconclusive for the reported fracture and expulsion as no objective evidence was provided for review.Furthermore, the clinical conditions 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.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 the litigation process that sometime post a port placement via the right subclavian vein, the port allegedly got fractured, and the port was eroded.It was further reported that the patient allegedly experienced redness and tenderness in the anterior chest wall surrounding the port and developed infection, and was diagnosed with cellulitis.Furthermore, the patient allegedly experienced chest pain.Reportedly, the port was removed and replaced.The current status of the patient is unknown.

• Brand Name: POWERPORT M.R.I. 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: 18500741
• MDR Text Key: 332725132
• Report Number: 3006260740-2023-06124
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741026980
• UDI-Public: (01)00801741026980
• 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,Followup
• Report Date: 04/17/2024

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: 1808001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/18/2023
• Initial Date FDA Received: 01/12/2024
• Supplement Dates Manufacturer Received: 02/21/2024; 04/24/2024
• Supplement Dates FDA Received: 02/26/2024; 04/26/2024
• 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: 49 YR
• Patient Sex: Female