MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® LUBRICATH® FOLEY CATHETER

Catalog Number 0119L22

Device Problem Inaccurate Flow Rate (1249)

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

Event Date 12/28/2021

Event Type  malfunction  

Event Description

It was reported that the user noticed no urine outflow from the catheter after placing the foley catheter.The catheter was under observation because a small amount of outflow was confirmed by milking.Later, when the user noticed urine leakage and checked the fixed water, it was 0 ml, and the catheter fell out.User stated that the water flowed out at once when 10ml was added again and 2 hours later, the fixed water was 0ml and the catheter fell out spontaneously.After removing the catheter, fixed water injection experiment was conducted multiple times as a post-verification in the medical safety management room.There was no leakage found and the results were inconsistent.It was also reported that no cracks were found in the balloon even when the balloon was pressurized.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that the user noticed no urine outflow from the catheter after placing the foley catheter.The catheter was under observation because a small amount of outflow was confirmed by milking.Later, when the user noticed urine leakage and checked the fixed water, it was 0 ml, and the catheter fell out.User stated that the water flowed out at once when 10ml was added again and 2 hours later, the fixed water was 0ml and the catheter fell out spontaneously.After removing the catheter, fixed water injection experiment was conducted multiple times as a post-verification in the medical safety management room.There was no leakage found and the results were inconsistent.It was also reported that no cracks were found in the balloon even when the balloon was pressurized.

Manufacturer Narrative

Upon further review, bd has determined that this mdr was reported in error as it was found to be a cascading failure of an event previously reported.

Event Description

It was reported that the user noticed no urine outflow from the catheter after placing the foley catheter.The catheter was under observation because a small amount of outflow was confirmed by milking.Later, when the user noticed urine leakage and checked the fixed water, it was 0 ml, and the catheter fell out.User stated that the water flowed out at once when 10ml was added again and 2 hours later, the fixed water was 0ml and the catheter fell out spontaneously.After removing the catheter, fixed water injection experiment was conducted multiple times as a post-verification in the medical safety management room.There was no leakage found and the results were inconsistent.It was also reported that no cracks were found in the balloon even when the balloon was pressurized.

• Brand Name: BARDEX® LUBRICATH® FOLEY CATHETER
• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13467713
• MDR Text Key: 286164147
• Report Number: 1018233-2022-00436
• Device Sequence Number: 1
• Product Code: EZC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K910846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0119L22
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other