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

Model Number	802414
Medical Device Problem Codes	Material Protrusion/Extrusion (2979); Sharp Edges (4013)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/24/2021
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 patient had difficulty in inserting the catheter.Per follow up via phone on (b)(6) 2021 the customer noted that the end of the catheter was very floppy because the holes were opposite each other so it kept bending during the insertion which made it painful and difficult to insert the first 3 inches of the catheter.The customer was still able to insert the catheter and void the bladder.The customer stated that the material on the catheter was not smooth and was a little rough.No medical intervention was required.
Additional Manufacturer Narrative
The reported event was unconfirmed since the device meets specifications.The product was used for treatment purposes.The product had not caused the reported failure, as lot samples were evaluated.No used samples were returned.87 red rubber catheters were returned unopened in original packaging.Per sampling plan, 13 catheters were selected at random for testing.All 13 catheters were inspected visually, and no defects were noted.No bumps on the catheters were noted.Catheter size and eye dimensions were measured, as it was reported the patient had difficulty inserting the catheter.All 13 catheters had the french size measured using a french gauge, and using a caliper had the catheter eye length, width, and the distance from catheter eye center to catheter tip measured.All 13 catheters meet specification for french size which states "french size specification is ±1 french size.".All 13 catheters meet eye width and length specification.All 13 catheters meet catheter eye center to catheter tip distance specification.All catheters met specification, which states, "no sharp lumps are allowed" and "smooth lumps no larger than two french sizes are allowed on shaft", as no lumps were noted.No root cause could be found because the reported event was unconfirmed.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.Labeling review is not required as the reported event was unconfirmed.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 actual/suspected device was inspected.
Event or Problem Description
It was reported that the patient had difficulty in inserting the catheter.Per follow up via phone on 24mar2021 the customer noted that the end of the catheter was very floppy because the holes were opposite each other so it kept bending during the insertion which made it painful and difficult to insert the first 3 inches of the catheter.The customer was still able to insert the catheter and void the bladder.The customer stated that the material on the catheter was not smooth and was a little rough.No medical intervention was required.

• Brand Name: BARDIA® 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 11701535
• Report Number: 1018233-2021-02278
• Device Sequence Number: 3909459
• Product Code: KOD
• UDI-Device Identifier: 00801741018350
• UDI-Public: (01)00801741018350
• 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): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2021

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: 06/30/2023
• Device Model Number: 802414
• Device Catalogue Number: 802414
• Device Lot Number: NGEN2837
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/24/2021
• Supplement Date Received by Manufacturer: 11/18/2021
• Initial Report FDA Received Date: 04/21/2021
• Supplement Report FDA Received Date: 11/19/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2020
• 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: Male