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

Model Number DIALYSIS UNKNOWN

Device Problem Break (1069)

Patient Problems Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/08/2022

Event Type  Injury  

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 catheter's red or blue end had developed a split/crack (back ends).There was no available repair kit and the catheter remained in use.There was no reported patient outcome.

Manufacturer Narrative

Additional info: e1 (facility name, street 1, city, country, postal code), g3 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.

Manufacturer Narrative

Additional information: a2, a3, a4(weight in lbs), b3, b5, d6a, e3, g1(manufacturer name, mfr contact first name, last name, street 2, mfr city, region, postal code, email and phone number), g2, g3, h1, h6 new information has been received pertaining to the event.This event has been reassessed and the reportability has been determined to be a serious injury.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 catheter was inserted on (b)(6), 2020.The venous (blue) lumen was documented to have a split/crack (back ends/luer adapter) on (b)(6), 2022 (2 years 3 months 2 weeks and 4 days before crack was noted).It was said that this patient¿s venous lumen was severely damaged and they were unable to continue using it.There was no available repair kit.The patient was being treated with single lumen dialysis and having insufficient dialysis until a safe replacement line was sourced.The patient was needing to have longer dialysis sessions, negatively impacting their quality of life.Additionally, manufacturer was contacted for advice on next steps, there was no repair kits available (out of stock), and datix (safety report) was completed, quality and safety team of the hospital investigated.The dated photographs taken of both catheter lumens, new monitoring assessment tool made to carryout daily assessment of lumens and catheter.The renal team researched different brand hemodialysis catheter to replace the ca theter.A new catheter was then inserted on (b)(6), 2022.There was no leak and tego was not utilized.Clinell 2% chlorhexidine in 70% alcohol individually wrapped wipes were the cleaning agent typically used on the device and specifically to clean the adapters.Hand was utilized to tighten the adapters and there was no excessive force used on catheter.There was nothing unusual documented at time of insertion and flushing was not documented at the time of insertion.All hemodialysis lines have the heparin lock withdrawn and lumen was flushed prior to every use.Clinell 2% chlorhexidine in 70% alcohol individually wrapped wipes, unisurge pack line on 3ml and 5ml syringes, gambro artiset blood tubing system for hemodialysis with gambro artis, unisurge pack line off 3ml and 5ml syringes, red uhs obturator cap, bd plastipak 20ml luer-lok syringe, bd vacutainer multiple sample luer adapter, bd vacutainer one-use holder (catalogue number: 364815) and bd vacutainer blood collection tubes were the products being utilized with the device.It was mentioned that all affected will need the catheter removed and replaced if appropriate due to the risk of infection and air embolus.There was no blood loss.

Manufacturer Narrative

Additional information: b5, g3 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 catheter was inserted on (b)(6) 2020.The venous (blue) lumen was documented to have a split/crack (back ends/luer adapter) on (b)(6) 2022 (2 years 3 months 2 weeks and 4 days before crack was noted).It was said that this patient¿s venous lumen was severely damaged and they were unable to continue using it.Additionally, manufacturer was contacted for advice on next steps, there was no repair kit available (out of stock), and datix (safety report) was completed, quality and safety team of the hospital investigated.The dated photographs taken of both catheter lumens, new monitoring assessment tool made to carryout daily assessment of lumens and catheter.The renal team researched different brand hemodialysis catheters to replace the catheter.There was no leak and tego was not utilized.Clinell 2% chlorhexidine in 70% alcohol individually wrapped wipes (ref: vjt638) were the cleaning agent typically used on the device and specifically to clean the adapters.Hand was utilized to tighten the adapters and there was no excessive force used on catheter.There was nothing unusual documented at time of insertion and flushing was not doc umented at the time of insertion.All hemodialysis lines have the heparin lock withdrawn and lumen was flushed prior to every use.Clinell 2% chlorhexidine in 70% alcohol individually wrapped wipes (ref: vjt638), unisurge pack line on 3ml and 5ml syringes (ref: f810557), gambro artiset blood tubing system for hemodialysis with gambro artis (ref: 955549), unisurge pack line off 3ml and 5ml syringes, red uhs obturator cap (ref: f810558), bd plastipak 20ml luer-lok syringe (ref: 300629), bd vacutainer multiple sample luer adapter (ref: 367300), bd vacutainer one-use holder (catalogue number: 364815) and bd vacutainer blood collection tubes (ref: 363095) were the products being utilized with the device.The patient was being treated with single lumen dialysis and having insufficient dialysis until a safe replacement line was sourced.The patient was needing to have longer dialysis sessions, negatively impacting their quality of life.The catheter was removed and replaced with a new catheter on (b)(6) 2022 due to the risk of infection and air embolus.There was no blood loss.

• 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 ; 5920 longbow drive; 8200 coral sea st ne; mounds view,mn, CO 55112 ; 7635265677
• MDR Report Key: 15026894
• MDR Text Key: 301753303
• Report Number: 3009211636-2022-00173
• Device Sequence Number: 1
• Product Code: FJS
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 06/25/2022
• Initial Date FDA Received: 07/15/2022
• Supplement Dates Manufacturer Received: 07/15/2022; 08/25/2022; 09/09/2022
• Supplement Dates FDA Received: 07/29/2022; 09/09/2022; 09/24/2022
• 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): Other
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 65 KG