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

Catalog Number 0165L14

Device Problem Device Handling Problem (3265)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/21/2023

Event Type  Injury  

Manufacturer Narrative

The reported event was confirmed ¿ user related.The reported failure was able to be reproduced.The product was used for urological care.The product had caused the reported failure.Based on evaluation.Observed the catheter was cut into two pieces.Sample has been examined under microscopic.The catheter shaft looks like it has been cut with applied force that could cause the catheter to split into two.Based on entry description, the catheter was broken due to patient tear it off.The potential root cause for this failure mode could be user related since the patient had torn off the catheter.The labeling and instructions for use were found to be adequate.The dhr review could not be performed without a lot number.Therefore no additional action required at this time.Section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Event Description

It was reported that a foley catheter was inserted on (b)(6) 2023, and foley was amputated on (b)(6) 2023, probably due to tearing off by the patient.As per the additional information received on 17jan2024, the event was also summarized as that the catheter had ruptured and there was a broken piece inside the patient's body.At the time of catheter rupture, the catheter remains inside the bladder.After that, the torn catheter was removed with forceps under cystoscopy, and the doctor determined that there was nothing left in the bladder.It was unknown what medical intervention was provided.

• 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 18614847
• MDR Text Key: 334215373
• Report Number: 1018233-2024-00357
• 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,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 0165L14
• Device Lot Number: MYHT1086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/21/2023
• 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): Required Intervention