MAUDE Adverse Event Report: MEDSOURCE INTERNATIONAL LLC SURESITE AUTO IV CATHETER 20G X 1.16; Catheter, intravascular, therapeutic, short-term less than 30 days

Model Number	DYNA20116
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/12/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The catheter separated from the hub.It was reported that it had to be surgically removed.
Event or Problem Description
The catheter became disconnected from the hub.It was stated that the catheter had to be surgically removed.

• Brand Name: SURESITE AUTO IV CATHETER 20G X 1.16
• Common Device Name: Catheter, intravascular, therapeutic, short-term less than 30 days
• Manufacturer (Section D): MEDSOURCE INTERNATIONAL LLC; medsource international llc; 8600 shelby ct; chanhassen MN 55317
• Manufacturer Contact: neeraj gupta ; 110-111 phase iv,; udyog vihar sector 18; haryana, gurugram 12201-5 ; IN 122015
• MDR Report Key: 18043818
• Report Number: 3003674698-2023-00523
• Device Sequence Number: 20868853
• Product Code: FOZ
• UDI-Device Identifier: 10888277667457
• UDI-Public: 10888277667457
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K161779
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/31/2023

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: DYNA20116
• Device Catalogue Number: DYNA20116
• Device Lot Number: 27822110011
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown