MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP Medline; CATHETER, IV, SURESITE AUTO, 24G X 0.56"

Model Number	DYNSCA24056
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	02/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, on (b)(6) 2023 when inserting the iv into the right arm, "the iv was inserted and the blood return did not occur until the iv was through the vessel".The customer reported "multiple" attempts to start the iv line were attempted and an iv was successfully inserted when "using a different catheter".The customer reported the infusion was able to be completed.Sample requested to be returned.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, 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 02/06/2023 when inserting the iv into the right arm, "the iv was inserted and the blood return did not occur until the iv was through the vessel".

• Brand Name: Medline
• Common Device Name: CATHETER, IV, SURESITE AUTO, 24G X 0.56"
• 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: 16497750
• Report Number: 1417592-2023-00091
• Device Sequence Number: 15065853
• Product Code: FOZ
• UDI-Device Identifier: 10193489007893
• UDI-Public: 10193489007893
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 03/07/2023

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: DYNSCA24056
• Device Catalogue Number: DYNSCA24056
• Device Lot Number: 2782207001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2023
• Initial Report FDA Received Date: 03/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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