MAUDE Adverse Event Report: MEDSOURCE INTERNATIONAL LLC CLEARSAFE COMFORT, 20 GA X 1"; SAFETY CATHETER

Model Number	MS-842202
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/24/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There was a reported incident where the catheter became disconnected from the hub.The patient was sent to the er to have the broken catheter surgically removed.
Event or Problem Description
There was a reported incident where the catheter became disconnected from the hub.The patient was sent to the er to have the broken catheter surgically removed.

• Brand Name: CLEARSAFE COMFORT, 20 GA X 1"
• Common Device Name: SAFETY CATHETER
• Manufacturer (Section D): MEDSOURCE INTERNATIONAL LLC; 8600 shelby court; chanhassen MN 55317
• Manufacturer Contact: neeraj gupta ; 110-111 phase iv; udyog vihar sector 18; haryana, gurugram 12201-5 ; IN 122015
• MDR Report Key: 19460715
• Report Number: 3003674698-2024-00760
• Device Sequence Number: 20498449
• Product Code: FOZ
• UDI-Device Identifier: 00816703020630
• UDI-Public: 00816703020630
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K150611
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: MS-842202
• Device Catalogue Number: MS-842202
• Device Lot Number: 31078/0673
• 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: 05/24/2024
• Initial Report FDA Received Date: 06/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/27/2023
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Male