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

Device Problems Difficult to Remove (1528); Failure to Deflate (4060)

Patient Problem Pain (1994)

Event Date 07/28/2021

Event Type  No Answer Provided  

Event Description

Bedside rn trying to remove foley; 10ml of water removed from balloon, syringe aspirated twice more to ensure no further water in balloon.Upon initial trial of removal patient experienced extreme pain.Balloon aspirated another time with no water removed.Foley eventually came out with resistance, upon inspection 5ml of water were still in balloon.No urethral bleeding noted, patient able to void without complications.Fda safety report id # (b)(4).

• Brand Name: BARD FOLEY
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): C. R. BARD, INC. ; covington GA 30014
• MDR Report Key: 12253823
• MDR Text Key: 264952583
• Report Number: MW5102879
• Device Sequence Number: 1
• Product Code: EZL
• 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: 07/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• 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: 68 YR