MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. PALINDROME; CATHETER, HEMODIALYSIS, IMPLANTED

Model Number 8888145057P

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

Patient Problems Bacterial Infection (1735); Fever (1858); Osteomyelitis (4533); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/20/2022

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the patient developed a catheter associated infection.The type of infection the patient had was osteomyelitis, bacteremia.Patient's symptoms prior to infection were fever, leukocytosis and positive blood cultures.It was stated that on (b)(6) 2022 the issue was observed through id (infectious disease) consultation.A recall alert was received by the customer on (b)(6) 2022.They alert the states that potential leaking at the hub had been identified by our side.The patient was identified to have a central line associated blood stream infection (clabsi) on the date of the event.The patient was transferred to ltac (long term acute care facility) with permanent hd line in place.The catheter was not repaired and there was no luer adapter issue.Tego was utilized.Alcohol pad was the cleaning agent used on the device.Chloraprep (duraprep for iodine allergy) was the cleaning agent used to treat the insertion site prior to product placement.There was nothing unusual observed on the device prior to use, no other defects/damages found on the product and flushing was performed prior to use.The catheter was replaced with a new device (unaffected lot) to resolve the issue and procedure was completed.Patient was given antibiotics intravenously and on (b)(6) 2022 the pat patient had below the knee amputation as intervention due to the event.Hospital length of stay increased due to infection.There was no blood loss and blood transfusion was not required.

Event Description

According to the reporter, the patient was admitted on (b)(6) 2022, catheter was inserted on (b)(6) 2022 and the patient had been identified to have a central line associated blood stream infection on (b)(6) 2022.The type of infection the patient had was osteomyelitis, bacteremia.Patient's symptoms prior to infection were fever, leukocytosis and positive blood cultures.On (b)(6) 2022, the issue was observed through id (infectious disease) consultation and it was confirmed.Id consultant believes that the infection came from osteomyelitis.A recall alert was received by the customer on (b)(6) 2022.They alert the states that potential leaking at the hub had been identified by our side.On (b)(6) 2022, the patient was transferred to ltac (long term acute care facility) with permanent hd line in place.The catheter was not repaired and there was no luer adapter issue.Tego was utilized.Alcohol pad was the cleaning agent used on the device.Chloraprep (duraprep for iodine allergy) was the cleaning agent used to treat the insertion site prior to product placement.There was nothing unusual observed on the device prior to use, no other defects/damages found on the product and flushing was performed prior to use with normal result and no other issues.Patient was given antibiotics intravenously and on (b)(6) 2022 the patient had below the knee amputation as intervention due to the event.On (b)(6) 2022, the catheter was replaced with a new device (unaffected lot) to resolve the issue and procedure was completed.Hospital length of stay increased due to infection.There was no blood loss and blood transfusion was not required.

Manufacturer Narrative

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: PALINDROME
• Type of Device: CATHETER, HEMODIALYSIS, IMPLANTED
• 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: 15331864
• MDR Text Key: 299040259
• Report Number: 3009211636-2022-00259
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 10884521158276
• UDI-Public: 10884521158276
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123196
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888145057P
• Device Catalogue Number: 8888145057P
• Device Lot Number: 2124600235
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2022
• 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
• Patient Outcome(s): Hospitalization; Disability; Other; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 88 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: American Indian Or Alaskan Native