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

Model Number 16FR 5CC RIBBED BALLOON CATHETER

Device Problems Inflation Problem (1310); Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/29/2022

Event Type  malfunction  

Event Description

Nurse was placing a 16 fr silicone foley in patient.Before placement, noticed foley said to inflate balloon with 16 ml of nacl (should have said 10 ml).Foley was discarded and new foley was opened and placed.Foley was saved and given to manager.Fda safety report id #(b)(4).

• Brand Name: CATHETER
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): C.R. BARD, INC.; covington GA 30014
• MDR Report Key: 15428283
• MDR Text Key: 300225194
• Report Number: MW5112058
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 09/12/2022

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 Model Number: 16FR 5CC RIBBED BALLOON CATHETER
• Device Catalogue Number: 165816
• Device Lot Number: NGGP3688
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/14/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1