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

Catalog Number	0165L28
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 1018233-2023-08504
• Device Sequence Number: 6445025
• Product Code: EZC
• UDI-Device Identifier: 00801741017544
• UDI-Public: (01)00801741017544
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2024

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/30/2024
• Device Catalogue Number: 0165L28
• Device Lot Number: NGGY3103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/27/2023
• Supplement Report FDA Received Date: 01/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown