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

Model Number	277712
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	12/20/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the red rubber catheter had irritated the patient's urethra and made the withdrawal difficult.It was noted that the patient had been using the product for more than 90 days.No medical intervention was reported.Per additional information received on 05nov2021, patient stated that the subbed catheters were hurting.Per follow-up via phone on 20dec2021, it was reported that the intermittent catheters were used for 3-4 weeks and it caused irritation.Customer stated that the catheters finish was not as smooth as what they normally used and the irritation cleared up without consulting a doctor.No medical intervention was reported.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be ¿under dried due to operator error ¿.It is unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.A dhr review could not be performed without a lot number.A labeling review was not performed because labeling could not have prevented the reported failure.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.
Event or Problem Description
It was reported that the red rubber catheter had irritated the patient's urethra and made the withdrawal difficult.It was noted that the patient had been using the product for more than 90 days.No medical intervention was reported.Per additional information received on 05nov2021, patient stated that the subbed catheters were hurting.Per follow-up via phone on 20dec2021, it was reported that the intermittent catheters were used for 3-4 weeks and it caused irritation.Customer stated that the catheters finish was not as smooth as what they normally used and the irritation cleared up without consulting a doctor.No medical intervention was reported.

• Brand Name: BARD® RUBBER UTILITY CATHETER
• Common Device Name: RUBBER UTILITY 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: 13120946
• Report Number: 1018233-2021-08586
• Device Sequence Number: 4562516
• Product Code: KOD
• UDI-Device Identifier: 00801741034091
• UDI-Public: (01)00801741034091
• 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): 03/09/2022

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: Lay User/Patient
• Device Model Number: 277712
• Device Catalogue Number: 277714
• 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: 12/20/2021
• Supplement Date Received by Manufacturer: 03/09/2022
• Initial Report FDA Received Date: 12/30/2021
• Supplement Report FDA Received Date: 04/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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