MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; DBD-CATHETER, IV, SURESITE AUTO, 20G X 1

Catalog Number	DYNSCA20100
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/11/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, on (b)(6) 2023 after inserting an intravenous catheter the nurse noted the "hub had blood leakage and moved too freely under the tegaderm".The customer reported after removing the tegaderm she noted the catheter was not connected to the hub.The customer reported there was a palpable "lump" under the skin and a physician had to perform "a cut-down procedure" to remove the catheter from the patient.The customer reported there was "no visible trauma to the catheter or its hub." sample requested for return evaluation.It has been determined that the reported event caused or contributed to serious injury, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
According to the customer, on (b)(6) 2023 after inserting an intravenous catheter the nurse noted the "hub had blood leakage and moved too freely under the tegaderm".The customer reported after removing the tegaderm she noted the catheter was not connected to the hub.

• Common Device Name: DBD-CATHETER, IV, SURESITE AUTO, 20G X 1
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 18207533
• Report Number: 1417592-2023-00463
• Device Sequence Number: 15069126
• Product Code: FOZ
• UDI-Device Identifier: 10888277667440
• UDI-Public: 10888277667440
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 11/24/2023

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 Catalogue Number: DYNSCA20100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2023
• Initial Report FDA Received Date: 11/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Unknown