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

Model Number	8888145057P
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during dialysis, a pin hole was noted and air was detected in the line by the dialysis machine.It was stated that the pin hole was located in the extension tubing at the base of the blue (venous lumen) adapter and leak was also observed.There was no crack or luer adapter issue.Catheter was exchanged and a new one was successfully inserted.Chloraprep was the cleaning agent used on the insertion site prior to product placement in the operating room and the surgeon used a betadine on the exchange.Flushing was done and the catheter functioned properly when originally inserted.There was no blood loss and blood transfusion was not required.The catheter was not repaired and no tego utilized.There were no other products being utilized with the device.There were no patient symptoms or complications associated with the event.There was no patient injury.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted there was a disconnection in the extension tube which led to a leak.Functionally, a water bath test was performed to observe leakage.The ends were clamped, and a syringe was used to inject air to observe leakage.Air bubbles were present on the extension tube of the blue luer adapter, a hole was noted.The red luer adapter passed with acceptable results.It was reported that there was a leak on the extension tube.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue may occur when contact is made with a sharp surgical instrument.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: exercise caution when using sharp instruments near the catheter.Catheter tubing can tear when subjected to nicks, excessive force, or rough edges.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.
Additional 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 or Problem Description
According to the reporter, on (b)(6) during dialysis, a pin hole was noted and air was detected in the line by the dialysis machine.It was stated that the pin hole was located in the extension tubing at the base of the blue (venous lumen) adapter and leak was also observed.There was no crack or luer adapter issue.On (b)(6), a new one was successfully inserted during exchange procedure.Chloraprep was the cleaning agent used on the insertion site prior to product placement in the operating room and the surgeon used a betadine on the exchange.Flushing was done and the catheter functioned properly when originally inserted.There was no blood loss and blood transfusion was not required.The catheter was not repaired and no tego utilized.There were no other products being ut ilized with the device.There were no patient symptoms or complications associated with the event.There was no patient injury.

• Brand Name: PALINDROME
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CS 20101
• MDR Report Key: 12211010
• Report Number: 3009211636-2021-00176
• Device Sequence Number: 4424961
• Product Code: MSD
• UDI-Device Identifier: 10884521158276
• UDI-Public: 10884521158276
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K123196
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/20/2021

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
• Operator of Device: Health Professional
• Device Model Number: 8888145057P
• Device Catalogue Number: 8888145057P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2021
• Initial Date Received by Manufacturer: 06/30/2021
• Supplement Date Received by Manufacturer: 07/20/2021; 09/03/2021
• Initial Report FDA Received Date: 07/22/2021
• Supplement Report FDA Received Date: 08/06/2021; 09/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 87 YR