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

Model Number A942216

Device Problems Material Puncture/Hole (1504); Device Fell (4014); Unintended Deflation (4061)

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

Event Type  malfunction  

Event Description

A 16fr foley catheter placed intraoperative without difficulty around 1230pm.The patient was flipped prone and the foley catheter was intact, secured and draining clear yellow urine.Crna emptied approx 200-300cc.At about 1500, it was noted that the foley catheter had fallen out of patient's penis and was on the floor under the jackson table.When i examined the balloon of the foley, it was deflated and appeared to have a hole in it.I used a syringe to try to add air to the balloon and it was in fact broken.

• Brand Name: FOLEY CATHETER
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): C.R. BARD, INC.
• MDR Report Key: 16529654
• MDR Text Key: 311219856
• Report Number: MW5115677
• 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: 03/09/2023

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 Model Number: A942216
• Device Catalogue Number: A942216
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/10/2023
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 104 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White