MAUDE Adverse Event Report: COVIDIEN LLC PALINDROME; CATHETER, HEMODIALYSIS, IMPLANTED

Model Number	8888145040P
Medical Device Problem Codes	Component Missing (2306); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during implantation, three cannulas (split airlock) of the kit were broken (split)/head torn, and one product had a sheath issue.It was also stated that the top of the splitting sheet disconnected from the shaft, so the catheter could not be placed into the patient.The inserter decided to use the split sheet from another kit of the same lot as the remedial action.There was no damage to the inner package and outer packaging.The sterile barrier was intact.There was no flushing prior to use.There was nothing unusual about the device before use.The treatment proceeded and was completed after the resolution of the split cannula was removed and restarted with a new set of procedures as the corrective action taken.The patient lost approximately 30 ml of blood, and a blood transfusion was not required.In addition to the reported issue, there were no other defects/damages to the product identified at the time of the event.There were no other products used with the device.There was no excessive force applied to the device.There were no cleaning agents used on the device.There was no problem with the luer adapter.There was no patient outcome.
Additional Manufacturer Narrative
D10 concomitant products: 8888145044cp, 8888145044cp 23cm p h kit vt ce, (lot #unknown) 8888145044cp, 8888145044cp 23cm p h kit vt ce, (lot #unknown) 8888145040p, 8888145040p 23 cm slot kit w/vt, (lot #2320000262).Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
According to the reporter, during implantation, three cannulas (split airlock) of the kit were broken (split)/head torn, and one product had a sheath issue.It was also stated that the top of the splitting sheet disconnect from the shaft, so the catheter could not be placed into the patient.The inserter decided to use the split sheet from another kit of the same lot as the remedial action.There was no damage to the inner package and outer packaging.The sterile barrier was intact.There was no flushing prior to use.There was nothing unusual about the device before use.The treatment proceeded and was completed after the resolution of the split cannula was removed and restarted with a new set of procedures as the corrective action taken.The patient lost approximately 30 ml of blood, and a blood transfusion was not required.In addition to the reported issue, there were no other defects/damages to the product identified at the time of the event.There were no other products used with the device.There was no excessive force applied to the device.There were no cleaning agents used on the device.There was no problem with the luer adapter.There was no patient outcome.
Additional Manufacturer Narrative
Additional information: b5, d2, d4, g3, h4.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
According to the reporter, during implantation, three cannulas (split airlock) of the kit were broken (split)/head torn.It was also stated that the top of the splitting sheet disconnect from the shaft, so the catheter could not be placed into the patient.The inserter decided to use the split sheet from another kit of the same lot as the remedial action.There was no damage to the inner package and outer packaging.The sterile barrier was intact.There was no flushing prior to use.There was nothing unusual about the device before use.The treatment proceeded and was completed after the resolution of the split cannula was removed and restarted with a new set of procedures as the corrective action taken.The patient lost approximately 30 ml of blood, and a blood transfusion was not required.In addition to the reported issue, there were no other defects/damages to the product identified at the time of the event.There were no other products used with the device.There was no excessive force applied to the device.There were no cleaning agents used on the device.There was no problem with the luer adapter.There was no patient outcome.
Additional Manufacturer Narrative
Additional information: g3, h6 additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned.Therefore, this event does not meet the reporting requirements in 21 cfr 803.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: PALINDROME
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): COVIDIEN LLC; 15 hampshire st; mansfield MA 02048
• Manufacturer (Section G): COVIDIEN LLC; 15 hampshire st; mansfield MA 02048
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 19638872
• Report Number: 1282497-2024-00185
• Device Sequence Number: 8345886
• Product Code: MSD
• UDI-Device Identifier: 10884521158030
• UDI-Public: 10884521158030
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K123196
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/07/2024
• 2 Devices were Involved in the Event: 1 2

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: 8888145040P
• Device Catalogue Number: 8888145040P
• Device Lot Number: 2320000262
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2024
• Supplement Date Received by Manufacturer: 07/31/2024; 09/10/2024; 09/30/2024
• Initial Report FDA Received Date: 06/28/2024
• Supplement Report FDA Received Date: 08/06/2024; 09/11/2024; 10/07/2024
• Date Device Manufactured: 08/04/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Patient Sex: Unknown