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

Model Number PERITONEAL CATHETER

Device Problems Migration or Expulsion of Device (1395); Product Quality Problem (1506)

Patient Problems Granuloma (1876); Unspecified Infection (1930)

Event Date 11/15/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the reporter, during use, the device had an unspecified issue.There was nothing unusual observed on the device prior to use, and it was confirmed that there was no defect or issue noted with the device that could have caused the patient's infection and granuloma.There was no intervention done for the patient's granuloma.

Manufacturer Narrative

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

Event Description

According to the reporter, during use, the device had a catheter migration (device was going out sometimes).There was nothing unusual observed on the device prior to use, and it was confirmed that there was no defect or issue noted with the device that could have caused the patient's infection and granuloma.It was noted that the cleaning agent used on the device was physiological serum (sterilium) with dried sterile gauze and a little iodine applied around it.The cleaning agents were not mixed.The patient's granuloma was treated with silver nitrate applications.The patient's infection was treated with 42.5 mg.Skin bar 2 times a week, cloxacillin 500mg per 6 hours, ciprofloxacin 250mg per 12 hours, fluconazole 100mg per day and topical treatment of ciprofloxacin otic.The patient was found to have suffered granuloma and infection of the subcutaneous tunnel.The patient is currently fine as a new tunnel has been performed and the old tunnel has been closed.

Manufacturer Narrative

Additional information: outcomes attributed to adverse event, description of event or problem, premarket identification, adverse event problem.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: PERITONEAL CATHETER
• Type of Device: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• MDR Report Key: 9455651
• MDR Text Key: 170460481
• Report Number: 3009211636-2019-00268
• 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: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 01/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PERITONEAL CATHETER
• Device Catalogue Number: PERITONEAL CATHETER
• Device Lot Number: 19B19880
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention