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

Model Number 8888145044CP

Device Problem Material Puncture/Hole (1504)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/14/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, the dialysis was started according to routine and everything looked as usual.It was stated that the dressing from the last dialysis was noted to be dry and clean.About the middle of the four hour treatment, it was stated that the patient was disconnected to the machine for a toilet visit.It was mentioned that everything was fine and the patient reconnected back to continue the treatment.At the end of dialysis, a blood was seen on patient's blouse and flushing was performed on the vein tube (blue tube) but leakage was noted where the clamp of the silicone tube extension.A small crack was seen and silicon extension was clamped with two extra clamps above the crack.It was also mentioned that original clamp was replaced and discarded.The catheter was not repaired and no issue noted on luer adapter.It was also mentioned on the report that insertion site was treated prior to insertion.Chlorhexidine was used as a cleaning agent on the device.There was no reported patient 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 dialysis was started according to routine and everything looked as usual.It was stated that the dressing from the last dialysis was noted to be dry and clean.About the middle of the four hour treatment, it was stated that the patient was disconnected from the machine for a toilet visit.It was mentioned that everything was fine and the patient reconnected back to continue the treatment.At the end of dialysis, a blood was seen on patient's blouse and flushing was performed on the vein tube(blue tube) but leakage was noted where the clamp of the silicone tube extension.A small crack was seen and silicon extension was clamped with two extra clamps above the crack, the physician put on a temporary slide clamp to turn off vein extension to stop the leak.It was reported that there was blood loss of 10ml and no transfusion was required.It was stated that the device was used as a s ingle catheter entry until they changed to a new device.The clamps was moved periodically.It was also mentioned that original clamp was replaced and discarded.They tried to repair the catheter with the repair kit but the hole was too far down on the silicone extension and they decided to replace the catheter.It was also mentioned on the report that insertion site was treated prior to insertion, nothing unusual was observed prior to use.Chlorhexidine was used as a cleaning agent on the device and cleaning agents was not mixed.There was no reported patient injury.

Event Description

According to the reporter, the dialysis was started according to routine and everything looked as usual.It was stated that the dressing from the last dialysis was noted to be dry and clean.About the middle of the four hour treatment, it was stated that the patient was disconnected from the machine for a toilet visit.It was mentioned that everything was fine and the patient reconnected back to continue the treatment.At the end of dialysis, a blood was seen on patient's blouse and flushing was performed on the vein tube (blue tube) but leakage was noted where the clamp of the silicone tube extension.A small crack was seen and silicon extension was clamped with two extra clamps above the crack, the physician put on a temporary slide clamp to turn off vein extension to stop the leak.It was reported that there was blood loss of 10ml and no transfusion was required.The clamps was moved periodically.It was also mentioned that original clamp was replaced and discarded.They tried to repair the catheter with the repair kit but the hole was too far down on the silicone extension and they decided to replace the catheter.It was also mentioned on the report that insertion site was treated prior to insertion, nothing unusual was observed prior to use.Chlorhexidine was used as a cleaning agent on the device and cleaning agents was not mixed.There was no reported patient injury.

Manufacturer Narrative

Additional info: b5, d6, d7, g4.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: g4, h6.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: h3 evaluation summary: post market vigilance (pmv) led a photographic evaluation of one device.The visual inspection of the returned photo noted: the image depicts the catheter being used on a patient, the luer adapter are capped and there is some blood around the clamps of the extension tubes.Without the physical product functional evaluations are precluded.A review of the device history record indicates this product was released meeting all quality release specifications at the time of manufacture.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition.A definitive root cause could not be determined with regard to the reported condition.Without the physical product, a definitive root cause could not be identified.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.

• Brand Name: PALINDROME
• Type of Device: CATHETER, HEMODIALYSIS, IMPLANTED, COATED
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• MDR Report Key: 9544095
• MDR Text Key: 194159084
• Report Number: 3009211636-2020-00006
• Device Sequence Number: 1
• Product Code: NYU
• UDI-Device Identifier: 10884521158085
• UDI-Public: 10884521158085
• Combination Product (y/n): N
• PMA/PMN Number: K123196
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/20/2021
• Device Model Number: 8888145044CP
• Device Catalogue Number: 8888145044CP
• Device Lot Number: 1901400108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2020
• Initial Date Manufacturer Received: 12/18/2019
• Initial Date FDA Received: 01/03/2020
• Supplement Dates Manufacturer Received: 01/10/2020; 01/22/2020; 02/14/2020; 03/02/2020
• Supplement Dates FDA Received: 01/22/2020; 02/04/2020; 03/02/2020; 03/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 89 YR
• Patient Weight: 62