MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. POWERGLIDE PRO MIDLINE CATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number	F118108P
Health Effect - Clinical Codes	Laceration(s) (1946); Foreign Body In Patient (2687)
Date of Event	06/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had an 18g right upper arm midline (basilic vein) catheter placed on (b)(6) 2023.On (b)(6) 2023 while at outpatient therapy to get his iv antibiotics the line was noted to be leaking.The rn pulled down the dressing and noticed the catheter hub and part of the catheter had broken off, leaving a part of the catheter in the patient's arm.The patient was taken to the ed(emergency dept) and then went to the operating room for a venotomy where the broken piece in the patient's arm was successfully removed.

• Brand Name: POWERGLIDE PRO MIDLINE CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.
• MDR Report Key: 17203755
• Report Number: MW5118848
• Device Sequence Number: 12564567
• Product Code: FOZ
• UDI-Device Identifier: 00801741140563
• UDI-Public: (01)00801741140563
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/21/2023

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 Expiration Date: 05/31/2024
• Device Model Number: F118108P
• Device Catalogue Number: F118108PT
• Device Lot Number: REHQ0957
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/23/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 66 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White