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

Catalog Number	120614
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	12/11/2023
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.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 the issue noticed about a month ago.Customer was experiencing discomfort with trying to use them and wanted to make us aware of the issue.There was a lot they received from the va.Customer stated that there were holes all over the catheter.Customer had one to return back for evaluation with lot# nghq0269.Per follow up via mail on 15nov2023, customer took out a box of catheter lot number nghv0201 to use and found out that it was defective.There was a hole below the tip and down the side, this caused pain and discomfort when inserted in the urethra and their bladder did not empty.No medical intervention was reported.Per follow up via mail on 11dec2023, the placement of the variation of holes in the catheters.I have kept three boxes of the catheters and returned rest to the company.The catheters had two different holes nowhere near the tip of the catheter.The one on the left side, as it was being inserted, would cause extreme irritation with lot# nghu0540.No medical intervention was reported.
Event or Problem Description
It was reported that the issue noticed about a month ago.Customer was experiencing discomfort with trying to use them and wanted to make us aware of the issue.There was a lot they received from the va.Customer stated that there were holes all over the catheter.Customer had one to return back for evaluation with lot# nghq0269.Per follow up via mail on 15nov2023, customer took out a box of catheter lot number nghv0201 to use and found out that it was defective.There was a hole below the tip and down the side, this caused pain and discomfort when inserted in the urethra and their bladder did not empty.No medical intervention was reported.Per follow up via mail on 11dec2023, the placement of the variation of holes in the catheters.I have kept three boxes of the catheters and returned rest to the company.The catheters had two different holes nowhere near the tip of the catheter.The one on the left side, as it was being inserted, would cause extreme irritation with lot# nghu0540.No medical intervention was reported.
Additional Manufacturer Narrative
The reported event was inconclusive since sample condition was poor.Visual evaluation of the returned photo sample noted one (with original packaging), 2 eye tiemann catheter.Visual inspection of the photo sample is poor therefore this investigation is considered inconclusive.A potential root cause for this failure mode could be ¿missing or incorrect position of tip indicator".A review of the risk document was performed for this investigation.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: "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.Caution: federal (u.S.A.) laws restricts this device to sale by or on the order of a physician." 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: 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 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 18401672
• Report Number: 1018233-2023-09283
• Device Sequence Number: 4020624
• Product Code: KOD
• UDI-Device Identifier: 00801741029967
• UDI-Public: (01)00801741029967
• 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): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2024

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: NGHU0540
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2023
• Supplement Date Received by Manufacturer: 04/18/2024
• Initial Report FDA Received Date: 12/27/2023
• Supplement Report FDA Received Date: 04/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2023
• 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