MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® URETHRAL CATHETER; INTERMITTENT CATHETER

Catalog Number	120616
Medical Device Problem Codes	Component Misassembled (4004); Wrong Label (4073)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that mismarked sizing.Packaging sated one size but when opened, the catheters were a different size.Supposed to be coude tip and some were not.Not the entire box, mismatched in the box.Customer requested need wrong sized and shaped catheters replaced.Per follow up via email on 04mar2025, it was reported that customer received about 3 or 4 mis-sized catheters; each was one size larger (#18 instead of #16) but were identified in the packaging as the smaller size.Customer have not received any such mismarked catheters since.The catheters that had defective coude tips were the correct size but misshapen to the extent that the tips had a very minimal coude curve that was considerably shallower than normal, and therefore unusable.Customer have retained a couple of such catheters.They would add that they had also received several catheters whose length, instead of being straight, were s-shaped and/or twisted.However, none of these defects have appeared in their latest shipment.In no cases have i been harmed or injured by catheters, only inconvenienced.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The reported product number is unknown.The udi number for this product is not available.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 mismarked sizing.Packaging sated one size but when opened, the catheters were a different size.Supposed to be coude tip and some were not.Not the entire box, mismatched in the box.Customer requested need wrong sized and shaped catheters replaced.Per follow up via email on 04mar2025, it was reported that customer received about 3 or 4 mis-sized catheters; each was one size larger (#18 instead of #16) but were identified in the packaging as the smaller size.Customer have not received any such mismarked catheters since.The catheters that had defective coude tips were the correct size but misshapen to the extent that the tips had a very minimal coude curve that was considerably shallower than normal, and therefore unusable.Customer have retained a couple of such catheters.They would add that they had also received several catheters whose length, instead of being straight, were s-shaped and/or twisted.However, none of these defects have appeared in their latest shipment.In no cases have i been harmed or injured by catheters, only inconvenienced.
Additional Manufacturer Narrative
The reported event was confirmed supplier related.Visual evaluation of the returned sample noted one unopened (with original packaging), urological catheter.Visual inspection of the sample noted no visual defects.Appears straight tip and not curve (label coude).16fr past eyelets, 12 fr at tip and eyelet.This does not meet specification which states "product must conform to packaging drawing.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: instructions for use: indications for use: for urological use only.Storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.Caution: this product contains natural rubber latex which may cause allergic reactions.Warnings: on latex and red rubber catheters, 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.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 failure, and/or to injury, illness or death of the patient.Note: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable local, state and federal laws and regulations.Urinary tract infection.Bleeding from the urethra.Irritation of the urethra.Instructions for intermittent catheters: 1.Wash your hands thoroughly with soap and water.2.Remove catheter from the pack.3.Position yourself comfortably, cleaning the opening of the urethra and surrounding area.4.Gently insert rounded end of catheter into urethra.5.When urine stops flowing, remove catheter from urethra.6.Dispose of catheter in accordance with local rules and regulations.7.Wash your hands.Caution: federal (u.S.A.) laws restrict this device to sale by or on the order of a physician." correction: d, e, f, g, 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® URETHRAL CATHETER
• Common Device Name: INTERMITTENT 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: 21662948
• Report Number: 1018233-2025-01882
• Device Sequence Number: 8347352
• Product Code: KOD
• UDI-Device Identifier: 00801741029974
• UDI-Public: (01)00801741029974(11)241009(17)281031(10)NGJW1012
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2025

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: 120616
• Device Lot Number: NGJW1012
• 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: 03/04/2025
• Supplement Date Received by Manufacturer: 06/10/2025
• Initial Report FDA Received Date: 03/21/2025
• Supplement Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2024
• 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