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

Model Number	120614
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event is confirmed, manufacturing related.The red rubber latex catheter was returned in the opened original packaging.White powdery substance was noted to be present within one of the packages.The powdery substance was confirmed to be snowfloss.Upon further evaluation, no eyelets were present on the catheter, this is out of specifications.The lack of drainage eyes was confirmed to be the cause of the snowfloss as this prevented water from flowing through the catheter during the wash/chlorination machine that would normally remove the release agent.The coude indicator aligned with the curve and the catheter was confirmed to be 14fr using a french a gauge.A potential root cause for this event could be operator error.As no patient involvement was reported the device was not used, however is intended for treatment purposes.No manufacturing issues or non-conformances were noted during review of the dhr that could have caused or contributed to the reported event.A label/pack review is not required as a review of the label could not have prevented the reported event.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.H3 other text : the actual/suspected device was inspected.
Event or Problem Description
It was reported that the tiemann catheter opened and ready to use and a white powder was found throughout the length of the catheter in the packaging.Stated that the package opened prior to use and not able to use.

• 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: 17260837
• Report Number: 1018233-2023-04911
• Device Sequence Number: 15431643
• Product Code: KOD
• UDI-Device Identifier: 00801741029967
• UDI-Public: (01)00801741029967
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 06/29/2023

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: Health Professional
• Device Model Number: 120614
• Device Catalogue Number: 120614
• Device Lot Number: NGGT4482
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2023
• Initial Report FDA Received Date: 07/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2022
• 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