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

Model Number	277716
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/03/2022
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 patient was having drainage issues with the use of all purpose catheter.Patient stated that the eyelets were too small and not draining all of the urine from bladder.Per additional information received via liberator on 03feb2022, it was stated that all purpose catheter felt like fiberglass and it causes bleeding.
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 was having drainage issues with the use of all purpose catheter.Patient stated that the eyelets were too small and not draining all of the urine from bladder.Per additional information received via liberator on (b)(6) 2022, it was stated that all purpose catheter felt like fiberglass and it causes bleeding.
Event or Problem Description
It was reported that the patient was having drainage issues with the use of all purpose catheter.Patient stated that the eyelets were too small and not draining all of the urine from bladder.Per additional information received via liberator on (b)(6) 2022, it was stated that all purpose catheter felt like fiberglass and it causes bleeding.
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".It was 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.The lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: x-ray opaque rubber: warning: 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.Storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.For urological use only.Caution: this product contains natural rubber latex which may cause allergic reactions.U.S.Product packaged in mexico sterile unless package is opened or damaged.Do not use if package is opened or damaged.Warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable laws and regulations." 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: BARD® RUBBER UTILITY CATHETER
• Common Device Name: BARD® 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: 13614971
• Report Number: 1018233-2022-00909
• Device Sequence Number: 14715172
• Product Code: KOD
• UDI-Device Identifier: 00801741034114
• UDI-Public: (01)00801741034114
• 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): 04/15/2022

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: 277716
• Device Catalogue Number: 277716
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2022
• Supplement Date Received by Manufacturer: 04/16/2022
• Initial Report FDA Received Date: 02/27/2022
• Supplement Report FDA Received Date: 05/11/2022
• 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