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

Catalog Number F118100T

Device Problems Difficult to Insert (1316); Difficult to Remove (1528); Difficult to Advance (2920)

Patient Problem Insufficient Information (4580)

Event Date 01/01/2023

Event Type  Injury  

Event Description

Rn attempting to insert powerglide pro midline catheter 18g/10cm in pt.The catheter would not engage and the "wings" would not function to advance the catheter.While attempting to remove it, the device seemed to have slight resistance, but was then able to be easily removed.Concern for device malfunction.

• Brand Name: BARD POWERGLIDE PRO MIDLINE CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEM, INC.
• MDR Report Key: 16246960
• MDR Text Key: 308248631
• Report Number: MW5114507
• 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: 01/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: F118100T
• Device Lot Number: REGW1343
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 98 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White