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

Model Number	802416
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2020
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 some catheters were in different sizes from the others.
Additional Manufacturer Narrative
The reported event was unconfirmed as the device meets the specifications.50 red rubber urethral catheters unopened in original packaging were returned.No obvious defects were seen.8 of the 42 lot (ngev1423) catheters were randomly selected for testing.All 8 catheters were verified to be 16 fr using the french gage.The product did not caused the reported failure.A potential root cause for this failure mode was unable to determine due to the reported issue was unconfirmed.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The labeling review was not required due to the reported event was unconfirmed.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 actual/suspected device was inspected.
Event or Problem Description
It was reported that some catheters were in different sizes from the others.Per investigator notification received on 02apr2021 during evaluation it was found that the catheter with corporate lot number (ngdv0112) was found to be the incorrect french size.

• Brand Name: BARDIA URETHRAL CATHETER
• Common Device Name: URETHRAL CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11089091
• Report Number: 1018233-2020-22106
• Device Sequence Number: 3561585
• Product Code: KOD
• UDI-Device Identifier: 00801741018367
• UDI-Public: (01)00801741018367
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 08/24/2021

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: 01/31/2025
• Device Model Number: 802416
• Device Catalogue Number: 802416
• Device Lot Number: NGEV1423
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2021
• Initial Date Received by Manufacturer: 12/07/2020
• Supplement Date Received by Manufacturer: 08/24/2021
• Initial Report FDA Received Date: 12/29/2020
• Supplement Report FDA Received Date: 09/15/2021
• 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