MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD CLEAN-CATH INTERMITTENT CATHETER

Model Number	421714
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	03/04/2021
Type of Reportable Event	Serious Injury
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 the catheters had a gross white substance on them perhaps from the package.It was stated the patient had a urinary tract infection went to the urologist and would be getting antibiotics later.The user further reported that approximately 7 catheters were bad.The user thought that while catheterizing the patient during the night they did not notice and catheterized the patient.
Additional Manufacturer Narrative
The reported event was inconclusive as no sample returned for evaluation.It was unknown whether the device had met specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.A potential root cause for this failure mode could be due to a defective components from the supplier.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The labeling review was unable to review due to the labeling could not have prevented the reported failure.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.
Event or Problem Description
It was reported that the catheters had a gross white substance on them perhaps from the package.It was stated the patient had a urinary tract infection went to the urologist and would be getting antibiotics later.The user further reported that approximately 7 catheters were bad.The user thought that while catheterizing the patient during the night they did not notice and catheterized the patient.

• Brand Name: BARD CLEAN-CATH INTERMITTENT CATHETER
• Common Device Name: INTERMITTENT CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11580343
• Report Number: 1018233-2021-01670
• Device Sequence Number: 11982315
• Product Code: KOD
• UDI-Device Identifier: 00801741038822
• UDI-Public: (01)00801741038822
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K802665
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/30/2024
• Device Model Number: 421714
• Device Catalogue Number: 421714
• Device Lot Number: NGDX4013
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/04/2021
• Supplement Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 03/28/2021
• Supplement Report FDA Received Date: 07/27/2021
• 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: Required Intervention