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

Device Problem Break (1069)

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

Event Date 01/23/2022

Event Type  Injury  

Event Description

A 20g 8cm midline catheter placement attempted in cephalic vein of the right upper arm.Catheter would not deploy over the guidewire into the vein.Device removed and was noticeably shorter in length than when introduced into the arm.Device was measured and compared to new/unused device of same size and length to reveal approx 2.5cm missing.Required surgical removal of the retained portion of the device.Fda safety report id# (b)(4).

• 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: 13453727
• MDR Text Key: 285182409
• Report Number: MW5107198
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/01/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/03/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female