MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. MIDLINE CATHETER KIT

Model Number	S4153108DGP
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Access to vein obtained, inserted wire through catheter, pulled catheter out.Advanced wire and patient complained of pain, pulled wire back.Healthcare provider was able to pull wire back a few centimeters, and then it was stuck with resistance felt.Patient required interventional radiology (ir) intervention for removal.

• Brand Name: MIDLINE CATHETER KIT
• Common Device Name: MIDLINE CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.; 605 north 5600 west; salt lake city UT 84116
• MDR Report Key: 19515269
• Report Number: 19515269
• Device Sequence Number: 7392073
• Product Code: PND
• UDI-Device Identifier: 00801741154027
• UDI-Public: (01)00801741154027(17)250331(10)REHX0528
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/08/2024
• Report Date (Section F): 02/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: S4153108DGP
• Device Catalogue Number: S4153108DGP
• Device Lot Number: REHX0528
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/11/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/11/2024
• 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
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Weight: 102 KG
• Patient Race: White
• Date Report Sent to FDA: 02/08/2024