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

Model Number 18 GAUGE 8 CM

Device Problems Break (1069); Failure to Advance (2524)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/13/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, during a midline catheter placement, the vein was accessed, however, the catheter was unable to be successfully threaded over the device's guide wire.The procedure was stopped and the device was withdrawn.Upon removal and inspection of the midline device, the guidewire was not present or attached to the device.X-ray obtained and revealed the presence of foreign body to the left lower calf.Patient was taken to the operating room for foreign body removal.Fda safety report id# (b)(4).

• 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: 15293249
• MDR Text Key: 298692445
• Report Number: MW5111701
• 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: 08/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 18 GAUGE 8 CM
• Device Lot Number: REGQ1489
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 2 YR
• Patient Sex: Male
• Patient Weight: 14 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White