MAUDE Adverse Event Report: C. R. BARD, INC. INDWELLING CATHETER W/ DRAIN BAG; CATHETER, RETENTION TYPE, BALLOON

Device Problem Deflation Problem (1149)

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

Event Date 11/22/2022

Event Type  malfunction  

Event Description

Foley catheter was placed in operating room due to c-section.Was patent and draining.Patent was being transferred to other labor bed, the nurse observed the foley catheter out of the patient and balloon had deflated.The patient did not realize the catheter has come out.No injury to the patient.Fda safety report id# (b)(4).

• Brand Name: INDWELLING CATHETER W/ DRAIN BAG
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): C. R. BARD, INC.
• MDR Report Key: 15879082
• MDR Text Key: 304516283
• Report Number: MW5113510
• 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: Nurse
• Type of Report: Initial
• Report Date: 11/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White