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

Catalog Number	120614
Medical Device Problem Codes	Incorrect Measurement (1383); Material Too Rigid or Stiff (1544)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/17/2025
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 lot of new intermittent catheters customer received was unsatisfactory.They were too stiff, the wall diameter appeared different and was having difficulty getting the catheter inserted.They had some bleeding when catheterizing.They stated the catheter appeared to be made out of a different material, but they were both material#120614.Old lot they liked nghz2033, new lot they did not like ngjt0067.No medical intervention was reported.
Additional Manufacturer Narrative
The reported event was inconclusive as no sample was returned for evaluation.It was unknown whether the device had met relevant specifications.A potential root cause for this failure mode could be drainage eyes too large causing weak tip.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 states the following: indications for use: for urological use only single use.Single patient use.Do not reuse do not use if package is open or damaged.Sterilized using ethylene oxide 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 petroleum 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 characteristic 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 regulation.Adverse reactions: urinary tract infection bleeding from urethra irritation of the urethra instruction 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.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.
Event or Problem Description
It was reported that lot of new intermittent catheters customer received was unsatisfactory.They were too stiff, the wall diameter appeared different and was having difficulty getting the catheter inserted.They had some bleeding when catheterizing.They stated the catheter appeared to be made out of a different material, but they were both material#120614.Old lot they liked nghz2033, new lot they did not like ngjt0067.No medical intervention was reported.

• Brand Name: BARD® URETHRAL CATHETER
• Common Device Name: INTERMITTENT 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: 21321528
• Report Number: 1018233-2025-00638
• Device Sequence Number: 8696960
• Product Code: KOD
• UDI-Device Identifier: 00801741029967
• UDI-Public: (01)00801741029967(11)240716(17)281031(10)NGJT0067
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2025

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: 120614
• Device Lot Number: NGJT0067
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2025
• Supplement Date Received by Manufacturer: 05/13/2025
• Initial Report FDA Received Date: 02/06/2025
• Supplement Report FDA Received Date: 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/16/2024
• 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