MAUDE Adverse Event Report: COVIDIEN LLC ULTRAFLO; CATHETER, HEMODIALYSIS, NON-IMPLANTED

Model Number 8888221220

Device Problems Break (1069); Defective Component (2292)

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

Event Date 02/09/2024

Event Type  malfunction  

Event Description

According to the reporter, a deformation was detected in the blue scalpel luer region.The syringe was connected, and during dialysis, air retraction occurred.A crack was observed on the luer adapter.They used another product to loosen or tighten the connection, and the site was the syringe in the blue scalpel luer region.The insertion site was not handled prior to product placement.Tego was not used.Isodine was the cleaning agent used in this device.There was no leak.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.

Manufacturer Narrative

Additional information: b5, d6a, d6b, d9, g3, h3, h6, updated rfr, fdd new information has been received, and reassessment of the complaint found that it is no longer a reportable issue.The event is no longer associated with a serious injury or potential for serious injury with reoccurrence.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 Description

According to the reporter, a deformation in shape (not crack) was detected in the blue scalpel luer region or v-side (venous) female luer adapter prior to use.The syringe was connected, and during dialysis, air retraction occurred.They used another product to loosen or tighten the connection, and the site was the syringe in the blue scalpel luer region.The insertion site was not handled prior to product placement.Tego was not used.Isodine was the cleaning agent used in the device, and it was typically utilized to clean the adapters.They rotated the adapters to thread or tighten.The blood circuit was used.Flushing was done prior to use and had no problems.The cleaning agent was allowed to dry thoroughly prior to applying ointment to the area.There was no leak.No other products were being utilized with the device.They responded with a puncture.The product was not replaced.The procedure was completed.There was no blood loss.A blood transfusion was not required.No intervention or treatment was required as a result of the event.There was no reported patient injury.

Manufacturer Narrative

Additional information: b5, d3 (mfr name, street 1, mfr city, mfr region, country code, postal code), d9 (latest return date), g3, h6 (rfr code) new information has been received pertaining to the event.This event has been reassessed and the reportability has been determined to be a malfunction.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 Description

According to the reporter, a deformation in shape (not crack) which meant there was a chip detected in the blue scalpel luer region or v-side (venous) female luer adapter prior to use.The syringe was connected, and during dialysis, air retraction occurred.They used another product to loosen or tighten the connection, and the site was the syringe in the blue scalpel luer region.The insertion site was not handled prior to product placement.Tego was not used.Isodine was the cleaning agent used in the device, and it was typically utilized to clean the adapters.They rotated the adapters to thread or tighten.The blood circuit of another company was used.Flushing was done prior to use and had no problems.The cleaning agent was allowed to dry thoroughly prior to applying ointment to the area.There was no leak.No other products were being utilized with the device.They responded with a puncture which meant that dialysis was performed without using a catheter, but by inserting a dialysis needle into another part of the body to complete the procedure and the procedure was completed.The catheter was not replaced.There was no blood loss.A blood transfusion was not required.No intervention or treatment was required as a result of the event.There was no reported patient injury.

Manufacturer Narrative

Correction: g3 (aware date should be may 3, 2024) 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.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: ULTRAFLO
• Type of Device: CATHETER, HEMODIALYSIS, NON-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: 18869161
• MDR Text Key: 337774289
• Report Number: 3009211636-2024-00076
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 10884521125735
• UDI-Public: 10884521125735
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K120674
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/06/2024

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 Model Number: 8888221220
• Device Catalogue Number: 8888221220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/20/2024
• Initial Date FDA Received: 03/08/2024
• Supplement Dates Manufacturer Received: 03/14/2024; 04/17/2024; 05/03/2024
• Supplement Dates FDA Received: 04/08/2024; 05/03/2024; 05/06/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1