MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. DIALYSIS UNKNOWN; CATHETER, PERITONEAL, LONG-TERM INDWELLING

Model Number DIALYSIS UNKNOWN

Device Problems Product Quality Problem (1506); Insufficient Information (3190)

Patient Problems Bacterial Infection (1735); Unintended Radiation Exposure (4565)

Event Date 11/30/2020

Event Type  Injury  

Manufacturer Narrative

Title: recurrent staphylococcus lugdunensis osteomyelitis of the lumbar spine in a patient on chronic hemodialysis source: journal of global infectious diseases/volume 12 issue 4 /october-december 2020 pages: 231-234.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature source of study, a case study presented a report of recurrent vertebral osteomyelitis due to staphylococcus lugdunensis, 7 months apart, in a man who was on chronic dialysis treatments through a tunneled vascular indwelling catheter.The patient presented with recurrent vertebral osteomyelitis and a dialysis-catheter associated bacteremia with staphylococcus lugdunensis.The hypothesis stated by the author was that staphylococcus lugdunensis colonized the patient¿s tunneled dialysis catheter which in time led to continued bacteremia and likely seeding to the vertebral bones.The dialysis access was a tunneled long-term indwelling catheter (permcath¿ minneapolis, mn) that was placed and had remained in place for the previous 12 months.The patient was tolerating hemodialysis treatments without complaints of fever, diaphoresis, rigors or shivering.Daily peripheral blood cultures showed continuous bacteremia for 5 days with staphylococcus lugdunensis.Sequential cultures from the dialysis catheter were also continuously growing staphylococcus lugdunensis.He underwent a radiographically guided aspiration of the l2-3 vertebral disc space due to high-fluid intensity seen on lumbar mri (magnetic resonance imaging) which grew staphylococcus lugdunensis.The patient completed a6-week cefazolin course received on hemodialysis days.In this case, the catheter was not removed during the first occurrence of osteomyelitis; however, the catheter was eventually removed, and a new long-term dialysis access was placed with 3 weeks of ongoing antibiotic therapy and subsequently documented negative blood cultures.

Manufacturer Narrative

Additional information: g3, h6.New information has been received pertaining to the event that medtronic device was not utilized in the study provided.This event has been reassessed and found not to be a complaint.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: DIALYSIS UNKNOWN
• Type of Device: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CS 20101
• MDR Report Key: 12030576
• MDR Text Key: 257167172
• Report Number: 3009211636-2021-00145
• Device Sequence Number: 1
• Product Code: FJS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 07/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DIALYSIS UNKNOWN
• Device Catalogue Number: DIALYSIS UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR