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

Model Number F118108P

Device Problems Break (1069); Fluid/Blood Leak (1250)

Patient Problems Laceration(s) (1946); Foreign Body In Patient (2687)

Event Date 06/20/2023

Event Type  Injury  

Event 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
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.
• MDR Report Key: 17203755
• MDR Text Key: 318100678
• Report Number: MW5118848
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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 Manufacturer Received: Not provided
• Initial Date FDA Received: 06/23/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 66 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White