MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDIA COUDE OLIVE TIP URETHRAL FOLEY CATHETER

Model Number	802512
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2021
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.
Event or Problem Description
It was reported that catheters were twisted, dark discoloring and unable to use them.
Additional Manufacturer Narrative
The reported event was inconclusive as no sample returned for evaluation.A potential root cause for this failure mode could be due to inappropriate package design.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: "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.Adverse reactions: 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." h11: section a through f - the information provided by bd represents all of 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.H3 other text : the device was not returned.
Event or Problem Description
It was reported that 10 catheters were in a different color and described them as being twisted and unable to use them.It was noted that 38 catheters were twisted darker discoloring and unable to use them.

• Brand Name: BARDIA COUDE OLIVE TIP URETHRAL FOLEY CATHETER
• Common Device Name: URETHRAL FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11272919
• Report Number: 1018233-2021-00244
• Device Sequence Number: 19716009
• Product Code: KOD
• UDI-Device Identifier: 00801741039034
• UDI-Public: (01)00801741039034
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2021

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: 02/28/2025
• Device Model Number: 802512
• Device Catalogue Number: 802516
• Device Lot Number: NGEV3328
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/11/2021
• Supplement Date Received by Manufacturer: 06/15/2021
• Initial Report FDA Received Date: 02/03/2021
• Supplement Report FDA Received Date: 07/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other