MAUDE Adverse Event Report: US SURGICAL PUERTO RICO MAHURKAR; CATHETER, HEMODIALYSIS, NON-IMPLANTED

Model Number 8888135161

Device Problem Material Puncture/Hole (1504)

Patient Problems Perforation of Vessels (2135); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/09/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, it was noted that there was a leakage at the junction of the venous extension tube and luer adapter.There was no cleaning agent used on the device.Tego was not utilized and there was no luer adapter issue.The insertion site was not treated prior to product placement.The complication or other effect on patient resulting from this event were re-implantation after extubation and vascular injury.

Manufacturer Narrative

Additional information: b5, d4(lot number), d6b, g3, h6 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, the catheter was implanted early in the morning, continuous crrt was required, in the afternoon, it was noted that there was a leakage at the junction of the venous extension tube and luer adapter and crack was found in it.There was no cleaning agent used on the device.Tego was not utilized and there was no luer adapter issue.The insertion site was not treated prior to product placement.Flushing was done using anormal saline and nothing unusual was observed prior to use.The catheter was replaced with a new catheter to resolve the issue.The complication or other effect on patient resulting from this event were re-implantation after extubation and vascular injury and no other intervention/treatment was provided to the patient aside from re-implantation and extubation.The need for repeated catheterization led to vascular damage but there was no vessel rupture found in the patient.There was no reported patient injury.

Manufacturer Narrative

Additional information: d3( mfr name, street1, mfr city, mfr region, country code, postal code), d9, g1, g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device and a photo were available for evaluation.Visual inspection noted there was a cut in the extension tube where it met the venous luer adapter.It was reported that there was a leak or hole on the extension tube.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.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: clamping repeatedly on the same spot could weaken the tubing and clamping near the adapter and hub should be avoided.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.

• Brand Name: MAHURKAR
• Type of Device: CATHETER, HEMODIALYSIS, NON-IMPLANTED
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer (Section G): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view,mn, CO 55112 ; 7635265677
• MDR Report Key: 13930200
• MDR Text Key: 288045166
• Report Number: 3009211636-2022-00080
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 10884521006355
• UDI-Public: 10884521006355
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K030209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/05/2022

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: 8888135161
• Device Catalogue Number: 8888135161
• Device Lot Number: 20099300099
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/11/2022
• Initial Date FDA Received: 03/28/2022
• Supplement Dates Manufacturer Received: 03/22/2022; 11/16/2022
• Supplement Dates FDA Received: 04/07/2022; 12/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Sex: Male