MAUDE Adverse Event Report: BD BARD POWERGLIDE PRO 18G MIDLINE; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Lot Number REEU2440

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 08/11/2021

Event Type  malfunction  

Event Description

Bard midline 18g powerglide pro, blunt end, 2 failed attempts due to defect of blunt tip to catheter.Successful 3rd attempt.Fda safety report id# (b)(4).

• Brand Name: BARD POWERGLIDE PRO 18G MIDLINE
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BD; franklin lakes NJ 07417 1880
• MDR Report Key: 12331636
• MDR Text Key: 267079990
• Report Number: MW5103282
• Device Sequence Number: 1
• Product Code: FOZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 08/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Lot Number: REEU2440
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 14 YR