MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® URETHRAL CATHETER ROBINSON MODEL

Catalog Number	056114
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2025
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.Udi format updated with available product information per gudid.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 their clinical staff stated that they noticed cracking in general purpose latex intermittent catheters [pcn #277710(batch #unk), (batch #ngfs3051), (batch #nghv0932), (batch #nggr2390), (batch #nggq3730], [pcn #277708 (batch #nghs3453), (batch #nggz0495), (batch #nggt3524), (batch #nggy3130), (batch #nggs2682], [pcn #94100 (batch #ngey3152], ]pcn #94180(batch #ngev4510], [pcn #56110(batch #ngfw2958], [pcn #56114(batch #nggv2774].They were concerned that they were brittle and could affect patient safety.Based off of their concerns, they swept their supply areas and found the catheters below to show the same characteristics.They would like to have those evaluated.They have also included a photo below, which shows the cracking.
Additional Manufacturer Narrative
The reported event was confirmed cause unknown.Visual evaluation of the returned one-photo sample noted one unopened (with original packaging), intermittent catheter.Visual inspection of the one-photo sample noted what appears to be some cracking on the shaft of the catheter.No actions can be taken at this time since a root cause was not identified.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: warning: do not use ointments or lubricants having a petrolatum base.They will damage latex.Visually inspect the product for any imperfections or surface deterioration prior to use.Storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.For urological use only.This is a single use device.Do not resterilize any portion of this device.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient.Udi format updated with available product information per gudid.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 their clinical staff stated that they noticed cracking in general purpose latex intermittent catheters [pcn #(b)(6) (batch #unk), (batch #ngfs3051), (batch #nghv0932), (batch #nggr2390), (batch #nggq3730], [pcn #(b)(6) (batch #nghs3453), (batch #nggz0495), (batch #nggt3524), (batch #nggy3130), (batch #nggs2682], [pcn #(b)(6) (batch #ngey3152], ]pcn #(b)(6) (batch #ngev4510], [pcn #(b)(6) (batch #ngfw2958], [pcn #(b)(6) (batch #nggv2774].They were concerned that they were brittle and could affect patient safety.Based off of their concerns, they swept their supply areas and found the catheters below to show the same characteristics.They would like to have those evaluated.They have also included a photo below, which shows the cracking.Per customer follow up information received via email on (b)(6) 2025, stated that there was no impact to the patient.

• Brand Name: BARDEX® URETHRAL CATHETER ROBINSON MODEL
• Common Device Name: URETHRAL 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 GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 21410168
• Report Number: 1018233-2025-01033
• Device Sequence Number: 21196145
• Product Code: KOD
• UDI-Device Identifier: 00801741033520
• UDI-Public: (01)00801741033520(11)221117(17)270630(10)NGGV2774
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2025

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 Catalogue Number: 056114
• Device Lot Number: NGGV2774
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2025
• Supplement Date Received by Manufacturer: 04/15/2025
• Initial Report FDA Received Date: 02/19/2025
• Supplement Report FDA Received Date: 04/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2022
• 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