MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® RUBBER UTILITY CATHETER

Catalog Number	277710
Medical Device Problem Codes	Naturally Worn (2988); 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 #(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.
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 #94120 (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.Per customer follow up information received via email on 05mar2025, stated that there was no impact to the patient.
Additional Manufacturer Narrative
The reported event was confirmed cause unknown.Visual evaluation of the returned one-photo sample noted one unopened (with original packaging) latex intermittent catheters.Visual inspection of the one-photo sample noted visual inspection of the one photo sample noted that the red rubber latex intermittent catheter appeared to have degradation on the catheter and the catheter shaft.This does not meet specification which states "the product/assembly must be free of visible, lose or etched foreign matter, solvent spills, hair, etc." no actions can be taken at this time since a root cause was not identified.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.The instructions for use were found adequate and state the following: caution: this product contains natural rubber latex which may cause allergic reactions.Single use do not resterilize sterile unless package is opened or damaged.Do not use if package is open or damaged.Storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Visually inspect the product for any imperfections or surface deterioration prior to use.Warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable laws and regulations.Correction: d, e, f, h.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.

• Brand Name: BARD® RUBBER UTILITY CATHETER
• Common Device Name: RUBBER UTILITY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 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: 21432196
• Report Number: 1018233-2025-01132
• Device Sequence Number: 4606615
• Product Code: KOD
• UDI-Device Identifier: 00801741034084
• UDI-Public: (01)00801741034084(11)220515(17)260131(10)NGGR2390
• 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): 08/29/2025

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 Expiration Date: 01/31/2026
• Device Catalogue Number: 277710
• Device Lot Number: NGGR2390
• 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: 08/29/2025
• Initial Report FDA Received Date: 02/21/2025
• Supplement Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2022
• 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