MAUDE Adverse Event Report: 3M HEALTH CARE MEDICAL SOLUTIONS DIVISION 3M¿ CUROS¿ DISINFECTING CAP FOR TEGO® HEMODIALYSIS CONNECTORS; LUER-FORMATTED DISINFECTION CAP

Model Number	N/A
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A hospital alleged 3m¿ curos¿ disinfecting cap for tego® hemodialysis connector, ctg1-270r connected to a male patient's cvc [central venous catheter].Upon removing the cap, the sponge was in the lumen of the cvc line.The patient's cvc line was replaced.
Additional Manufacturer Narrative
Age or date of birth-race: not provided.Lot and expiration date are unknown.Device manufacture date is unknown.Device has not been received for evaluation.Without a sample available, it is not possible to evaluate the sample for any defects or perform any tests to determine if the device met specification.The instructions for use states, 3m¿ curos¿ disinfecting cap for tego® hemodialysis connectors is a specially designed cap compatible* with tego® hemodialysis connectors.

• Brand Name: 3M¿ CUROS¿ DISINFECTING CAP FOR TEGO® HEMODIALYSIS CONNECTORS
• Common Device Name: LUER-FORMATTED DISINFECTION CAP
• Manufacturer (Section D): 3M HEALTH CARE MEDICAL SOLUTIONS DIVISION; 3m center, building 275-5w-06; 2510 conway ave; st. paul MN 55144
• Manufacturer (Section G): 3M COMPANY 3M COLUMBIA; 5400 paris road; colombia MO 65202
• Manufacturer Contact: dianne gibbs ; 3m center, building 275-5w-06; 2510 conway ave; st. paul, MN 55144 ; 6517379117
• MDR Report Key: 15520560
• Report Number: 2110898-2022-00096
• Device Sequence Number: 2506714
• Product Code: LKB
• UDI-Device Identifier: 30707387773817
• UDI-Public: 30707387773817
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K111992
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/30/2022

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 Model Number: N/A
• Device Catalogue Number: CTG1-270R
• 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: 09/02/2022
• Initial Report FDA Received Date: 09/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Male