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

Model Number	8813793009
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2025
Type of Reportable Event	Malfunction
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, prior to use, when flushing, it was found that the catheter had a water leakage from the iv (intravenous) connector silicone tubing (exit site) near luer adapter.It was also stated that there was a small hole in the iv connector silicone tubing.There was nothing unusual observed on the device aside from the issue.The catheter was not repaired.There was no damage to the external packaging.Aside from the reported issue, there were no other visible defects/damages found on the product at the time of the event.As a remedial action, the reported product was replaced with a new catheter.There was no patient involvement.
Additional Manufacturer Narrative
Correction: b5.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, prior to use, when flushing, it was found that the catheter had a water leakage from the iv connector silicone tubing near the (exit site) blue/venous luer adapter.It was also stated that there was a small hole in the iv connector silicone tubing near the blue/venous luer adapter.There was nothing unusual observed on the device aside from the issue.The catheter was not repaired.There was no damage to the external packaging.Aside from the reported issue, there were no other visible defects/damages found on the product at the time of the event.As a remedial action, the reported product was replaced with a new catheter.There was no patient involvement.
Additional Manufacturer Narrative
Additional information: h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device and a photo were available for evaluation.Visual inspection noted one catheter, with a pin-hole leak.There appeared to be no abnormalities with the device.It was reported that there was a leak.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue can occur, when the catheter came into contact with a sharp instrument during use.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.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.
Additional Manufacturer Narrative
Additional information: 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 that one catheter, with no signs of use.Upon first inspection, there appeared to be no visual abnormalities with the returned device.The device was then clamped and both extension tubes were flushed with water.A pin-hole leak was detected in the venous extension tube after flushing was performed.It was reported that there was a leak on the extension tube at or near the luer adapter.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue can occur when the catheter came into contact with a sharp instrument while preparing for the operation.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.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: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 22583493
• Report Number: 1282497-2025-00518
• Device Sequence Number: 11897148
• Product Code: FOZ
• UDI-Device Identifier: 10884521004801
• UDI-Public: (01)10884521004801(17)270630(10)2221000229
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K192302
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/28/2025

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: 8813793009
• Device Catalogue Number: 8813793009
• Device Lot Number: 2221000229
• 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: 07/08/2025
• Supplement Date Received by Manufacturer: 08/07/2025; 08/18/2025; 08/27/2025
• Initial Report FDA Received Date: 07/23/2025
• Supplement Report FDA Received Date: 08/08/2025; 08/19/2025; 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2022
• 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