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

Model Number 8888145045CP

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, on flushing at the end of a treatment, the line fell apart from the triangle plastic that had the holes for anchoring stitches.It snapped on the arterial lumen side.The catheter was not repaired.There was no 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, on flushing at the end of a treatment, the line fell apart from the triangle plastic that had the holes for anchoring stitches.These was no leak until the red line/arterial lumen side burst/snapped at the junction of the two lines.The blood burst out of the line half way through its saline flush.There was about 50ml of blood loss all over the carpet and bed quilt.The burst was sudden.There was evidence that the plastic bubbled before splitting, as though there was a sudden flow blockage, however, saline and blood flowed out immediately which did not support the notion of something blocking the line.Blood transfusion was not required.Nothing unusual observed prior to use of the product.Flushing was done prior to use with 0.9% saline by using 10ml syringe.The health professional was trained to flush firmly to clear lines and it was the method for almost three years.A tunnel line was the type of blood line being connected.It was not cross threaded.The catheter was not repaired.Tego was utilized.There was no luer adapter issue.Octenilin was the ointment utilized at the exit site.A bio-patch covered by a mepore dressing used as wound dressing which included cleaning agents or antimicrobial properties.They wiped the area dry before applying dressings and no ointments, only cleaning agent.The patient was responsible for catheter maintenance.The cleaning agent was not switched over the life of the catheter.The cleaning agent was not mixed.The site did not use sepsiderm to clean the catheter and urokinase was occasionally used to clean inside a sticky lumen.There was no protocol change for cleaning agents used recently.The patient was not using themselves any type of cleaning agent or antibiotic on the catheter.Line replacement using new catheters from another brand was done as intervention to resolve the issue.It took five days and two attempts to replace the line.In that time the patient could not dialyze.The second attempt to replace was on (b)(4) and it did not buckle.There was no patient injury.

• Brand Name: PALINDROME
• Type of Device: CATHETER, HEMODIALYSIS, IMPLANTED, COATED
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CS 20101
• MDR Report Key: 11504990
• MDR Text Key: 240352339
• Report Number: 3009211636-2021-00063
• Device Sequence Number: 1
• Product Code: NYU
• UDI-Device Identifier: 10884521158108
• UDI-Public: 10884521158108
• 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
• Report Date: 04/05/2021

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: 04/13/2020
• Device Model Number: 8888145045CP
• Device Catalogue Number: 8888145045CP
• Device Lot Number: 1713300158
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/23/2021
• Initial Date FDA Received: 03/17/2021
• Supplement Dates Manufacturer Received: 03/15/2021
• Supplement Dates FDA Received: 04/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR