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

Catalog Number 0165L28

Device Problem Incorrect Measurement (1383)

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

Event Date 11/07/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: 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 the patient ordered foley catheter and the current lot received were not the correct size.Per additional information received via phone on 13nov2023, customer experienced a sizing issue.Customer thought that the foley catheter was smaller than they have been before, the packaging said 28 but customer felt they were getting 26.Customer stated that this was frequently happening to where they had at least one the wrong size from every order, but this order customer had about 8 of them.Customer stated that they were all from the same lot.

Event Description

It was reported that the patient ordered foley catheter and the current lot# received were not the correct size.Per additional information received via phone on 13nov2023, customer experienced a sizing issue.Customer thought that the foley catheter was smaller than they have been before, the packaging said 28 but customer felt they were getting 26.Customer stated that this was frequently happening to where they had at least one the wrong size from every order, but this order customer had about 8 of them.Customer stated that they were all from the same lot.Per additional information received on 29nov2023, it was reported that the foley catheter was painful at insertion site and bloody and swollen (pr# 9321806).No medical intervention was reported.Per additional information received on 08dec2023, the catheter was causing a severe irritation pain inside my bladder.They did not know if that was also causing the redness externally or if the redness was caused by some sort if skin irritation from the catheter.No medical intervention was reported.

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.H11: 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.

• 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: 18209199
• MDR Text Key: 329012569
• Report Number: 1018233-2023-08504
• Device Sequence Number: 1
• Product Code: EZC
• UDI-Device Identifier: 00801741017544
• UDI-Public: (01)00801741017544
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K910846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 0165L28
• Device Lot Number: NGGY3103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2024
• 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