MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; ARTERIAL LINE KIT

Catalog Number	DYNJ47006C
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/28/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility on (b)(6) 2024, during pre-surgical insertion of an arterial line, when placing an arterial line in patient, the wire got stuck in the catheter and when pulled out of the patient, the wire came unwound.There was no harm to patient.The device was removed and they obtained a new arterial line for reinsertion.The procedure was completed on the opposite arm and the procedure was completed.The vfacility stated there was no serious injury or medical follow-up.A sample is not available for evaluation.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.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 facility on (b)(6) 2024, during pre-surgical insertion of an arterial line, when placing an arterial line in patient, the wire got stuck in the catheter and when pulled out of the patient, the wire came unwound.There was no harm to patient.
Additional Manufacturer Narrative
Updated h10: related report numbers.

• Common Device Name: ARTERIAL LINE KIT
• 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: 21161368
• Report Number: 1423395-2025-00005
• Device Sequence Number: 12861874
• Product Code: OFF
• UDI-Device Identifier: 40195327176878
• UDI-Public: 40195327176878
• 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,Followup
• Report Date (Section B): 01/16/2025

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 Expiration Date: 11/30/2025
• Device Catalogue Number: DYNJ47006C
• Device Lot Number: 24FMA872
• 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: 12/19/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/15/2025
• Supplement Report FDA Received Date: 01/16/2025
• 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: 74 YR
• Patient Sex: Female
• Patient Weight: 63 KG