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

Model Number	8832539002
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 evaluation summarry: medtronic conducted an investigation based upon all information received.The involved device was not returned.However, a video was provided.Visual inspection noted that there was a cut in the extension tube where it met the venous luer adapter.The placement of the cut suggests it was created by clamping the tubing too close to the luer adapter.Clamping the extension tube close to the luer adapter can cause excess stress on the extension tubing which can lead to breaks/leaks in the tubing where it connects to the luer adapter.It was reported that the luer adapter was leaking, cracked or broken.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 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, the child required plasma exchange treatment due to hypercholesterolemia.On (b)(6) 2024, he was transferred to the pediatric icu for ultrasound-guided central venous catheterization.An 8fr hemodialysis catheter was inserted at 10:00 with a depth of 10 cm.The aspiration was smooth, and the infusion was unobstructed.The catheter was flushed with normal saline and locally fixed.The vital signs were stable during the operation, and there was no obvious bleeding from the puncture site after the operation.At 15:00, the hemodialysis catheter was aspirated before the plasma exchange operation, and a crack was found in the hemodialysis catheter.After re-disinfection and draping, after a guide wire was inserted at the original hemodialysis catheter, the original hemodialysis catheter was removed.The catheter had been placed for five hours.The catheter was not repaired.There was no leak.Tego was not utilized.There was a crack on the luer adapter.Nothing unusual observed on the device prior to use.Besides the reported issue, there were no other defects/damages found on the product.No instrument was used to loosen or tighten the device.The insertion site was treated with iodine disinfection prior to product placement.No other product is being utilized with the device.No excessive force was used on the device.As a remedial action, a new 8fr hemodialysis catheter was inserted again with a depth of 10 cm.The aspiration was smooth, and the infusion was unobstructed.The catheter was flushed with normal saline and locally fixed.Plasma exchange treatment continued.The intervention/treatment required was tube removal and re-cannulation.There was no blood loss, and blood transfusion was not required.There was no reported patient injury.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.A video was also provided.Visual inspection noted that there was a cut in the extension tube where it met the venous luer adapter.The placement of the cut suggests it was created by clamping the tubing too close to the luer adapter.Clamping the extension tube close to the luer adapter can cause excess stress on the extension tubing which can lead to breaks/leaks in the tubing where it connects to the luer adapter.It was reported that the luer adapter was leaking, cracked or broken.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 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: MAHURKAR
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• 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: 20926339
• Report Number: 1282497-2024-20039
• Device Sequence Number: 14734861
• Product Code: FOZ
• UDI-Device Identifier: 20884521005317
• UDI-Public: 20884521005317
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K192302
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2025

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: 8832539002
• Device Catalogue Number: 8832539002
• Device Lot Number: 2233300267
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2024
• Supplement Date Received by Manufacturer: 12/23/2024
• Initial Report FDA Received Date: 12/13/2024
• Supplement Report FDA Received Date: 01/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2022
• 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
• Patient Sex: Unknown