MAUDE Adverse Event Report: MEDSOURCE INTERNATIONAL, LLC. MEDLINE SURESITE IV AUTO SAFETY IV CATHETER, 20G X 1.00"; Catheter, intravascular, therapeutic, short-term less than 30 days

Model Number	DYNA20100
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Today when the diagnostic imaging staff were removing the patient's iv after a procedure, the catheter was retained in her left arm.The patient was taken to the ed and then vascular surgery had to do a cut down to extract the iv catheter from the patient.I'm still waiting to hear back from the ed if the catheter was saved.As of 08/21/2024, we have not yet been informed if the catheter was saved.

• Brand Name: MEDLINE SURESITE IV AUTO SAFETY IV CATHETER, 20G X 1.00"
• Common Device Name: Catheter, intravascular, therapeutic, short-term less than 30 days
• Manufacturer (Section D): 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: 20031395
• Report Number: 3003674698-2024-00806
• Device Sequence Number: 14221784
• Product Code: FOZ
• UDI-Device Identifier: 10193489140095
• UDI-Public: 10193489140095
• 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: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/21/2024

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
• Device Model Number: DYNA20100
• Device Catalogue Number: DYNA20100
• Device Lot Number: 27823110001
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/30/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Female