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

Model Number	120612
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2022
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 the intermittent catheters were clogging and unable to use even after irrigation.Per follow up on (b)(6) 2022, it was reported that the intermittent catheters were clogging even after irrigation and stated that there was no medical intervention needed for the customer.
Additional Manufacturer Narrative
The reported event was inconclusive due to lack of information.107 orange coude tip catheters were returned unopened in original packaging.20 catheters were selected at random for testing via sampling plan, general inspection level (ii); f.Catheters were visual inspected and no discoloration, or damage was noted.Each catheter had the drainage funnel attached to a di water fountain.Water was able to flow through each drainage funnel and out the catheter eyes without issue.No occlusion was noted.Catheters meet visual specification for "flat funnels" as funnel meets specification.As only lot samples were returned the reported, it is unknown if the reported product met specification or caused the reported event.Therefore the reported event is inconclusive.It was unknown whether the product had caused the reported failure.A potential root cause for this failure mode could be, "operator error".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: "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." 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 intermittent catheters were clogging and unable to use even after irrigation.The affected lots were(lot# ngft5816, lot# ngfu4453, lot# ngfr1186).Per follow up on (b)(6) 2022, it was reported that the intermittent catheters were clogging even after irrigation and stated that there was no medical intervention needed for the customer.

• 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13694275
• Report Number: 1018233-2022-01134
• Device Sequence Number: 13929611
• Product Code: KOD
• UDI-Device Identifier: 00801741029950
• UDI-Public: (01)00801741029950
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2022

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 Expiration Date: 05/31/2025
• Device Model Number: 120612
• Device Catalogue Number: 120612
• Device Lot Number: NGFR1186
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2022
• Supplement Date Received by Manufacturer: 07/06/2022
• Initial Report FDA Received Date: 03/08/2022
• Supplement Report FDA Received Date: 07/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2021
• 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