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

Model Number DIALYSIS UNKNOWN

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

Patient Problem Bacterial Infection (1735)

Event Date 07/16/2022

Event Type  Injury  

Manufacturer Narrative

Title: tunneled catheter-related bacteremia in hemodialysis patients: incidence, risk factors and outcomes.A 14-year observational study source: journal of nephrology, https://doi.Org/10.1007/s40620-022-01408-8.Received: 28 march 2022 / accepted: 16 july 2022.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.

Event Description

According to the literature, a 14-year period retrospective study analyzed the incidence of bacteremia of 325 patients who underwent 406 tunneled catheter placements between 2005 and 2019.A total of 462 tunneled catheters were implanted in 381 patients over a period of 14 years.Fifty-six patients were excluded due to their follow-up in another hospital area.To their knowledge, none of them had tunneled catheter-related bacteremia.Therefore, 325 patients with a total of 406 tunneled catheters.The tunneled catheter or another unspecified device was placed.The catheter was placed a total of 192 times with 24 incidences of tunneled catheter related bacteremia.The improvement in hospital care, the promotion of diagnosis and early initiation of antibiotic therapy.Of 325 patients, 57 (17.5%) suffered at least one episode of tunneled catheter-related bacteremia.A total of 85 cases of tunneled catheter-related bacteremia were diagnosed, resulting in an incidence of 0.40 per 1000 catheter days (81.1% after 6 months of implantation).The catheter was placed a total of 192 times with 24 incidences of tunneled catheter related bacteremia.The authors also report 24 cases of catheter removal due to ¿tunneled catheter dysfunction¿ but provide no additional details.

• 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
• Manufacturer (Section G): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CS 20101
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 15614446
• MDR Text Key: 301822463
• Report Number: 3009211636-2022-00302
• Device Sequence Number: 1
• Product Code: FJS
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2022
• 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
• Treatment: DIALYSIS UNKNOWN (LOT#UNKNOWN)
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male