MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A.; KIT, REPAIR, CATHETER, HEMODIALYSIS

Model Number	8888200001
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2022
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 was implanted in the patient for 4 to 5 months.The repair kit was used on (b)(6) 2022 (to repair the catheter and tego was screwed on by hand on the lumen of the repair kit).During normal usage, a crack was observed at the lumen level of the venous luer adapter using tego.The adapters were usually tightened by hand; they never used tools/instruments to loosen or tighten the device and they did not tighten the tego too much.There was no leak.70% alcohol per ifu was the cleaning agent used on the device and used to clean the adapters.The cleaning agent was allowed to dry thoroughly prior to applying ointment to the area.Nothing unusual was observed on the device prior to use and flushing was performed with good result.Bloodlines were being utilized with the device aside from tego.The catheter was not replaced.When they saw that the lumen of the repair kit was broken, they took it off and replaced it with another repair kit lumen to resolve the issue.Procedure was completed.There was no blood loss and blood transfusion was not required.There was no intervention/treatment required as a result of the event.The patient was in stable condition and there was no reported patient injury.

• Brand Name: NA
• Common Device Name: KIT, REPAIR, CATHETER, HEMODIALYSIS
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CS 20101
• Manufacturer (Section G): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CS 20101
• Manufacturer Contact: clay chandler ; 5920 longbow drive; boulder, CO 80301 ; 3035306409
• MDR Report Key: 13693907
• Report Number: 3009211636-2022-00060
• Device Sequence Number: 5295373
• Product Code: NFK
• UDI-Device Identifier: 10884521056282
• UDI-Public: 10884521056282
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K092797
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/08/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/14/2026
• Device Model Number: 8888200001
• Device Catalogue Number: 8888200001
• Device Lot Number: 2116600096
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2022
• Initial Report FDA Received Date: 03/08/2022
• 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