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

Catalog Number 4808560

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

Patient Problems Bacterial Infection (1735); Unspecified Infection (1930); Pneumonia (2011); Sepsis (2067)

Event Date 03/24/2022

Event Type  Injury  

Event Description

It was reported through the litigation process that two years eight months twenty two days post port placement via right internal jugular vein for administration of intravenous immunoglobulin infusions in treatment of chronic inflammatory demyelinating polyneuritis, the port developed an infection that led to sepsis.In additional patient was diagnosed with pneumonia.In addition patient was on cefazolin to treat the infection and physical therapy to try to alleviate lower back pain and regain mobility.However, the current status of the patent is unknown.

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 provide 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 years eight months twenty two days post port placement via right internal jugular vein for administration of intravenous immunoglobulin infusions in treatment of chronic inflammatory demyelinating polyneuritis, the port developed an infection that led to sepsis.In additional patient was diagnosed with pneumonia.In addition patient was on cefazolin to treat the infection and physical therapy to try to alleviate lower back pain and regain mobility.Reportedly, the port was removed.However, the current status of the patent is unknown.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not requested as the lot number reported as unknown.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately two years and eight months post port placement, patient presented to the emergency department with the complaints of fever, chills, vomiting, abdominal bloating, and does have back pain as well.Patient is diagnosed as sepsis due to mssa gram positive bacteremia port related.Around two days later, patient underwent excision of power port due to sepsis.Purulence in port pocket identified.Therefore, the investigation is inconclusive as no objective evidence has been provided to confirm any alleged deficiency with the port.Furthermore, 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 provide 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.

• Brand Name: POWERPORT ISP M.R.I. IMPLANTABLE PORT, GROSHONG 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: 17593854
• MDR Text Key: 321630528
• Report Number: 3006260740-2023-03601
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741027345
• UDI-Public: (01)00801741027345
• 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: 02/03/2024

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: 4808560
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/27/2023
• Initial Date FDA Received: 08/22/2023
• Supplement Dates Manufacturer Received: 02/02/2024
• Supplement Dates FDA Received: 02/15/2024
• 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: 69 YR
• Patient Sex: Male