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

Model Number A947316

Device Problems Inflation Problem (1310); Device Slipped (1584)

Patient Problem Insufficient Information (4580)

Event Date 04/30/2021

Event Type  malfunction  

Event Description

Pt retaining urine, foley catheter ordered.Upon inserting foley and ensuring adequate drainage, balloon was inflated however it did not anchor and foley came out.Upon further inspection, balloon was found to only inflate unilaterally.A second foley was inserted with the same incident of the balloon not anchoring and foley almost slipping out while still draining adequately.Charge nurse was notified as well as spd.Fda safety report id # (b)(4).

• Brand Name: BARD FOLEY CATHETER
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): C.R. BARD, INC.
• MDR Report Key: 11831358
• MDR Text Key: 251218670
• Report Number: MW5101364
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 05/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A947316
• Device Catalogue Number: A947316
• Device Lot Number: PK7645924
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: 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