MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; CATHETER, IV, SURESITE AUTO, 20G X 1.00

Catalog Number	DYNA20100Z
Medical Device Problem Code	Break (1069)
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 customer, on (b)(6) 2024 when removing the iv catheter after a "heart coronary angiography" the catheter was retained in the patient's "left median antecubital vein".
Additional Manufacturer Narrative
According to the customer, on (b)(6) 2024 when removing the iv catheter after a "heart coronary angiography" the catheter was retained in the patient's "left median antecubital vein".The customer reported the retained catheter was confirmed under ultrasound.The customer reported the patient required a "cut down on the vein" under "local anesthesia", and the catheter was extracted by a "vascular surgeon".The customer reported the procedure was able to be completed and the patient was "discharged home".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.

• Common Device Name: CATHETER, IV, SURESITE AUTO, 20G X 1.00
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes dr; northfield IL 60093 2753
• Manufacturer Contact: danielle tognocchi ; three lakes dr; northfield, IL 60093-2753
• MDR Report Key: 20031052
• Report Number: 1417592-2024-00817
• Device Sequence Number: 6395370
• Product Code: BSY
• UDI-Device Identifier: 20193489140108
• UDI-Public: 20193489140108
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Nurse
• 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
• Operator of Device: Health Professional
• Device Catalogue Number: DYNA20100Z
• Device Lot Number: 27823110001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2024
• Initial Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/30/2023
• 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
• Patient Weight: 137 KG