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

Model Number	802214
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2022
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 nurse caring for the patient attempted to perform a straight catheterization to obtain a urine specimen.The urethral catheter folded over on itself.The customer took a new, clean, catheter and tried to perform on a manikin, and the same thing happened and the device did not do what it was supposed to do.
Event or Problem Description
It was reported that the nurse caring for the patient attempted to perform a straight catheterization to obtain a urine specimen.The urethral catheter folded over on itself.The customer took a new, clean, catheter and tried to perform on a manikin, and the same thing happened and the device did not do what it was supposed to do.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be "rough or irregular shape protrusions".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: "remove tray lid.Place underpad beneath patient, plastic side down.Put on cuffed gloves.Position drape on patient.Open lubricant.Lubricate catheter.Open packet of swabs.Prep patient with swabs.Proceed with catheterization in usual manner.If specimen is required, fill sterile container from catheter.If urine is placed in specimen jar: secure cap.Label specimen jar.Send specimen to laboratory." h11: section a through f - the information provided by bard 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 bard.H3 other text: the device was not returned.

• Brand Name: BARDIA® URETHRAL CATHETER TRAY, CLEAR PLASTIC CATHETER
• Common Device Name: URETHRAL CATHETER TRAY
• 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: 16536604
• Report Number: 1018233-2023-01704
• Device Sequence Number: 6007490
• Product Code: KOD
• UDI-Device Identifier: 00801741018404
• UDI-Public: (01)00801741018404
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2023

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 Expiration Date: 04/30/2026
• Device Model Number: 802214
• Device Catalogue Number: 802214
• Device Lot Number: NGGT4452
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/21/2023
• Supplement Date Received by Manufacturer: 04/28/2023
• Initial Report FDA Received Date: 03/14/2023
• Supplement Report FDA Received Date: 05/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2022
• 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 Age: 80 YR
• Patient Sex: Male