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

Model Number 8888145040P

Device Problems Break (1069); Obstruction of Flow (2423)

Patient Problem Insufficient Information (4580)

Event Date 11/27/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, during flushing of the device, catheter fracture occurred (extreme it essentially exploded) and there was a leak at the junction of extension tube and bifurcate.It was stated that the catheter was in placed for two weeks.The catheter was not repaired.There was no tego utilized and no luer adapter issue.The catheter was removed and a new "cvad" was inserted.There was no reported patient outcome.

Manufacturer Narrative

H3: evaluation summary: medtronic conducted an investigation based upon all information received.The involved device was not returned.Visual inspection noted that the extension tube for the blue luer adapter was cut close to the adapter.A syringe was received attached to the adapter at the proximal end.Functional testing showed no signs of cracks.It was reported that there was a leak on the catheter shaft and the device was occluded.The reported issues could not be confirmed.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.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, during flushing of the device prior to use, the catheter was blocked and effectively ¿exploded¿ when the clinician was trying to flush the lumens and hence a section from the hub up to the extension tubing detached creating the 2nd piece.It was stated that there was a leak at the junction of extension tube and bifurcate but no blood transfusion required.It was also stated that the catheter was in placed for two weeks.2% chlohexindine in 70% alcohol as the cleaning agent used on the device and its entirety.The catheter was not repaired.There was no tego utilized and no luer adapter issue.The catheter was removed and a new "cvad" was inserted.The patient was treated with local anesthesia during insertion of a new catheter.Chg dressing included any cleaning agents or antimicrobial properties was used as wound dressing.The cleaning agent allowed to dry thoroughly prior to dressing the area.There was no other product being utilized with the device.There was no sepsiderm used to clean the catheter and the protocol was not changed for the cleaning agent used recently.There was no prescribed or over-the-counter treatment.The cleaning agents was not mixed and ever switched over the life of the catheter.There was no other defects or damages found on the device aside for the evidence of wear and tear from the clamp.There was no patient injury.

• Brand Name: PALINDROME
• Type of Device: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CS 20101
• MDR Report Key: 11055133
• MDR Text Key: 223624376
• Report Number: 3009211636-2020-00314
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 10884521158030
• UDI-Public: 10884521158030
• 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: 02/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888145040P
• Device Catalogue Number: 8888145040P
• Device Lot Number: 2017500123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2020
• Date Manufacturer Received: 01/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1