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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. DIALYSIS UNKNOWN; CATHETER, PERITONEAL, LONG-TERM INDWELLING
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COVIDIEN MFG SOLUTIONS S.A. DIALYSIS UNKNOWN; CATHETER, PERITONEAL, LONG-TERM INDWELLING Back to Search Results
Model Number DIALYSIS UNKNOWN
Device Problem Break (1069)
Patient Problem Peritonitis (2252)
Event Date 11/09/2019
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, the pd (peritoneal dialysis) catheter was cut from the exit side area that caused peritonitis to the patient.The patient was not hospitalized for the event and a peritoneal effluent sample was taken for analysis and culture.It was also stated that the patient was treated with vancomycin injection (1 gram every 3 days, route and duration were not reported) for peritonitis.It was mentioned that the patient never used dianeal 1.5% pd2 but only using the dianeal 2.5%pd2.The cause of the peritonitis was due to the catheter leakage.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, the pd (peritoneal dialysis) catheter was cut from the exit side area that caused peritonitis to the patient.The patient was not hospitalized for the event and a peritoneal effluent sample was taken for analysis and culture.It was also stated that the patient was treated with vancomycin injection (1 gram every 3 days, route and duration were not reported) for peritonitis.It was mentioned that the patient never used dianeal 1.5% pd2 but only using the dianeal 2.5%pd2.The cause of the peritonitis was the catheter leakage and the leak came from the middle portion of the catheter.There was no blood loss and blood transfusion was not needed.It was also stated that the catheter was not removed/replaced, there was no other product being utilized with the device, t-bact was utilized as the ointment for the exit site, betadine was used to clean the entire catheter, sterilize gauze was used for wound dressing, the cleaning agents were allowed to dry thoroughly prior to dressing the area and the cleaning agents were not mixed.The protocol for the cleaning agents was not changed and the patient was responsible for any type of catheter maintenance.
 
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.
 
Event Description
According to the reporter, the pd (peritoneal dialysis) catheter was cut from the exit side area that caused peritonitis to the patient.The patient was not hospitalized for the event and a peritoneal effluent sample was taken for analysis and culture.The patient was treated with antibiotic injection (1 gram every 3 days, route and duration were not reported) for peritonitis.The patient never used 1.5% pd2 but only using the 2.5%pd2.The cause of the peritonitis was the catheter leakage and the leak was came from the middle portion of the catheter.The catheter was not removed/replaced, there was no other product being utilized with the device, ointment was utilized as the ointment for the exit site, first-aid solution was used to clean the entire catheter, sterilize gauze was used for wound dressing, the cleaning agents were allowed to dry thoroughly prior to dressing the area and the cleaning agents were not mixed.The protocol for the cleaning agents was not changed and the patient was responsible for any type of catheter maintenance.
 
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.
 
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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
MDR Report Key9497783
MDR Text Key172413495
Report Number3009211636-2019-00277
Device Sequence Number1
Product Code FJS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup,Followup,Followup
Report Date 06/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberDIALYSIS UNKNOWN
Device Catalogue NumberDIALYSIS UNKNOWN
Device Lot Number19C142
Was Device Available for Evaluation? No
Date Manufacturer Received06/05/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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