MAUDE Adverse Event Report: MAHURKAR; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number	8817145005
Medical Device Problem Codes	Material Puncture/Hole (1504); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2021
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, the catheter had been in place for 3 weeks and during the dialysis treatment, the catheter broke at the junction of the tubing and the blue port just above the clamp.Blood started leaking while catheter was in use.Continuous renal replacement therapy (crrt) was the one being connected.Nothing unusual was observed on the device prior to use and flushing was done with patent result.Chlorhexidine gluconate (chg)/alcohol was used to clean the adapters and no ointment was applied to the area.The catheter was not repaired previously and tego was not utilized.There was no luer adapter issue.There were no other product being utilized with the device and hands were used to tighten the adapters.The clamps were not moved to a new location after each treatment.The catheter was removed and the child was put under general anesthesia to have another catheter placed.There was minimal blood loss as a result of the event and blood transfusion was not required.The patient had no injury and remained in the icu.
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, the catheter had been in place for 3 weeks and during the dialysis treatment while the patient was in icu, the catheter cracked at the junction of the tubing and the blue port just above the clamp (but the luer adapter did not detach from the extension tube).Blood started leaking while catheter was in use.Continuous renal replacement therapy (crrt) was the one being connected.Nothing unusual was observed on the device prior to use and flushing was done with patent result.Chlorhexidine gluconate (chg)/alcohol was used to clean the adapters and no ointment was applied to the area.The catheter was not repaired previously and tego was not utilized.There was no luer adapter issue.There were no other product being utilized with the device and hands were used to tighten the adapters.The clamps were not moved to a new location after each treatment.The catheter was removed and the child was put under general anesthesia to have another catheter placed.There was minimal blood loss as a result of the event and blood transfusion was not required.The patient had no injury and remained in the icu.
Additional Manufacturer Narrative
H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was not returned, but a photo was available for evaluation.The evaluation found no potentially contributing factors.It was reported that there was a leak on the extension tube.The reported issue could not be confirmed.The most likely cause could not be identified because no related problem was detected with the device.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.

• Brand Name: MAHURKAR
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• MDR Report Key: 12017707
• Report Number: 3009211636-2021-00140
• Device Sequence Number: 14588556
• Product Code: FOZ
• UDI-Device Identifier: 10884521005013
• UDI-Public: 10884521005013
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K943349
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/09/2021

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: 8817145005
• Device Catalogue Number: 8817145005
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/27/2021
• Supplement Date Received by Manufacturer: 07/23/2021; 09/01/2021
• Initial Report FDA Received Date: 06/17/2021
• Supplement Report FDA Received Date: 08/10/2021; 09/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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