MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD CLEAN-CATH INTERMITTENT CATHETER; COUDE INTERMITTENT CATHETER

Model Number	423714
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Patient Problem/Medical Problem (2688)
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 by the patient that the catheter felt a bit rough and caused bleeding.No medical intervention was reported.
Additional Manufacturer Narrative
The reported event was inconclusive.No sample was returned for evaluation.A potential failure mode for this could be "does not allow for easy insertion/removal of the catheter".A potential root cause for this failure mode could be, ¿too little coating applied to catheter surface¿.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: "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.Do not use if package is damaged.Bard and clean-cath are trademarks and /or registered trademarks of c.R.Bard, inc.Or affiliate.Warning: after use, this product may be a potential biohazard.Handle and dispose in accordance with accepted medical practice and applicable laws and regulations." 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 by the patient that the catheter felt a bit rough and caused bleeding.No medical intervention was reported.

• Brand Name: BARD CLEAN-CATH INTERMITTENT CATHETER
• Common Device Name: COUDE INTERMITTENT CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10290271
• Report Number: 1018233-2020-04640
• Device Sequence Number: 11416191
• Product Code: KOD
• UDI-Device Identifier: 00801741038877
• UDI-Public: (01)00801741038877
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K802665
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2020

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: 423714
• Device Catalogue Number: 423714
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/26/2020
• Supplement Date Received by Manufacturer: 09/02/2020
• Initial Report FDA Received Date: 07/17/2020
• Supplement Report FDA Received Date: 09/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1