MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; CATHETER, IV, SURESITE AUTO, 20G X 1.16"

Catalog Number	DYNA20116
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the facility on (b)(6) 2024 , "they attempted to start iv prior to procedure.The iv was started in left arm and noted leaking around insertion site.When removing iv catheter, plastic tip remained in patient.".
Additional Manufacturer Narrative
According to the facility on (b)(6) 2024 , "they attempted to start iv prior to procedure.The iv was started in left arm and noted leaking around insertion site.When removing iv catheter, plastic tip remained in patient.The radiologist was notified and the patient was sent to er.The patient required an excision of the foreign body in the left upper extremity at bedside by a vascular surgeon.The wound was closed with running continuous #3-0 vicryl suture in a deep layer".It has been determined that the reported event caused or contributed to serious injury requiring medical intervention, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Additional Manufacturer Narrative
Updated e4 initial reporter also sent the report to fda.

• Common Device Name: CATHETER, IV, SURESITE AUTO, 20G X 1.16"
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: alex mathew ; three lakes drive; northfield, IL 60093-2753 ; 2249317042
• MDR Report Key: 20344804
• Report Number: 1417592-2024-00872
• Device Sequence Number: 15405070
• Product Code: FOZ
• UDI-Device Identifier: 30193489140099
• UDI-Public: 30193489140099
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2024

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 Catalogue Number: DYNA20116
• Device Lot Number: 27823110001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/01/2024
• Supplement Report FDA Received Date: 10/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 37 YR
• Patient Sex: Female