MAUDE Adverse Event Report: MEDSOURCE INTERNATIONAL LLC MEDSOURCE; CLEARSAFE COMFORT SAFETY I.V. CATHETER, 20 GA X 1 IN

Model Number	MS-842202
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer advised that a 37 year old male patient, was at the clinic to receive vitamin therapy via iv.It was advised that as the clinical staff was inserting the catheter, it broke off in the patients arm.The patient was sent to the emergency room when the breakage occurred on (b)(6).The office was advised by the patient that the emergency room was unable to removed the catheter and was advised to wait a few days for the wound to settle before following up with a private surgeon.The patient followed up with a private surgeon on (b)(6) and was at the surgeons' clinic from 9am until 12pm, in the bed with the surgeon attempting to remove the broken catheter.Ultimately the surgeon advised that the catheter had settled in the patients muscle and they are unable to safely remove it and it was recommended to leave it alone.
Event or Problem Description
The customer advised that a 37 year old male patient, was at the clinic to receive vitamin therapy via iv.It was advised that as the clinical staff was inserting the catheter, it broke off in the patients arm.The patient was sent to the emergency room when the breakage occurred on (b)(6).The office was advised by the patient that the emergency room was unable to removed the catheter and was advised to wait a few days for the wound to settle before following up with a private surgeon.The patient followed up with a private surgeon on (b)(6) and was at the surgeons' clinic from 9am until 12pm, in the bed with the surgeon attempting to remove the broken catheter.Ultimately the surgeon advised that the catheter had settled in the patients muscle and they are unable to safely remove it and it was recommended to leave it alone.

• Brand Name: MEDSOURCE
• Common Device Name: CLEARSAFE COMFORT SAFETY I.V. CATHETER, 20 GA X 1 IN
• Manufacturer (Section D): MEDSOURCE INTERNATIONAL LLC; 8600 shelby court; suite 100; chanhassen MN 55317
• Manufacturer Contact: neeraj gupta ; 110-111 phase iv; udyog vihar sector 18; haryana, gurugram 12201-5 ; IN 122015
• MDR Report Key: 19600252
• Report Number: 3003674698-2024-00772
• Device Sequence Number: 8121729
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/24/2024

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2024
• Initial Report FDA Received Date: 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/31/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male