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

Model Number 12010BPT

Patient Problems Pain (1994); Rupture (2208)

Event Date 08/22/2023

Event Type  Injury  

Event Description

Patient was in need of iv access, midline was attempted in left arm in the basilic vein with a 20g/10cm long catheter.Sterile technique was obtained.Midline needle was inserted, guide wire was advanced.Attempt to advanced catheter, however patient yelled in pain.Placement was checked via ultrasound and it was found vein had ruptured.All attempts were stop,guide wire was retracted, catheter was retracted and midline device was taken out, pressure bandage applied.When looking at device it was found a half centimeter was missing.

• Brand Name: BARD POWERGLIDE MIDLINE CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.
• MDR Report Key: 17736780
• MDR Text Key: 323402507
• Report Number: MW5145572
• 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: 09/07/2023

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 Model Number: 12010BPT
• Device Lot Number: REHS4784
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/12/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 44 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White