MAUDE Adverse Event Report: BARD ACCESS SYSTEMS / C. R. BARD, INC. BARD ACCESS SYSTEMS; CATHETER, RETENTION TYPE, BALLOON

Model Number REF 303416A

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 09/28/2021

Event Type  malfunction  

Event Description

When placing the foley, the tip of the 10ml syringe used to fill the foley broke off in the port and drained sterile water out of the balloon.Another foley package was opened and used without incident.Fda safety report id# (b)(4).

• Brand Name: BARD ACCESS SYSTEMS
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): BARD ACCESS SYSTEMS / C. R. BARD, INC.
• MDR Report Key: 13118078
• MDR Text Key: 283137724
• Report Number: MW5106361
• Device Sequence Number: 1
• Product Code: EZL
• 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: 12/27/2021

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 Expiration Date: 06/30/2023
• Device Model Number: REF 303416A
• Device Lot Number: NGFU2466
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 20 YR
• Patient Sex: Female
• Patient Race: White