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

Model Number	F120108PT
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	03/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient received an ultrasound guided midline iv catheter to undergo a nuclear medicine stress test.Iv was placed in the right basilic vein without complication.Blood return without coaxing was observed.Radioactive tracer and saline flush was completed.Upon completion of the procedure, the catheter was advanced out without resistance; however, only 1 cm of tubing was removed.The other 9 cm of catheter tubing had severed off inside the patient's vein.Subsequent imaging identified that a 6.5 cm catheter fragment had migrated within the right descending pulmonary artery extending into a segmental branch of the right lower lobe pulmonary artery.Fda safety report id# (b)(4).

• Brand Name: BD POWERGLIDE PRO RT MIDLINE CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.; salt lake city UT 84116
• MDR Report Key: 14014616
• Report Number: MW5108747
• Device Sequence Number: 2632347
• Product Code: FOZ
• UDI-Device Identifier: 00801741140587
• UDI-Public: (01)00801741140587
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 03/31/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: F120108PT
• Device Catalogue Number: F120108PT
• Device Lot Number: REFY1503
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/04/2022
• 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: Other; Life Threatening; Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White