MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD URETHRAL CATHETERIZATION TRAY WITH RED RUBBER CATHETER

Model Number	772415
Medical Device Problem Code	Inaccurate Flow Rate (1249)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2020
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.The device was not returned.
Event or Problem Description
It was reported that despite correct anatomical location placement, the straight catheter did not drain urine.A second straight catheter was then placed in the same location and urine was returned.
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 used for the treatment purposes.A potential root cause for this failure mode could be due to kinked or partially collapsed drainage lumen which resulted in insufficient drainage of urine from the bladder.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: "visually inspect the product for any imperfections or surface deterioration prior to use.Instructions for use: 1.Open csr wrap to form sterile field.2.Place under pad beneath patient, plastic side down.3.Put on cuffed gloves.4.Position drape on patient.5.Remove top tray.6.Open lubrication-lubricate catheter.7.Prep patient with povidone-iodine swab sticks.8.Proceed with catheterization in usual manner.9.If specimen is required, fill sterile container from catheter.10.Top tray may be placed on basin to help prevent spillage." 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 device was not returned.
Event or Problem Description
It was reported that despite correct anatomical location placement the straight catheter did not drain the urine.A second straight catheter was placed in the same location and the urine was returned.

• Brand Name: BARD URETHRAL CATHETERIZATION TRAY WITH RED RUBBER CATHETER
• Common Device Name: RED RUBBER CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 10950723
• Report Number: 1018233-2020-21379
• Device Sequence Number: 14205047
• Product Code: KOD
• UDI-Device Identifier: 00801741030413
• UDI-Public: (01)00801741030413
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2021

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: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: 772415
• Device Catalogue Number: 772415
• Device Lot Number: NGEU2085
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/09/2020
• Supplement Date Received by Manufacturer: 02/23/2021
• Initial Report FDA Received Date: 12/05/2020
• Supplement Report FDA Received Date: 03/19/2021
• 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