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

Model Number	423710
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Codes	Abrasion (1689); Hematuria (2558); Blood Loss (2597)
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 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.The device was not returned.
Event or Problem Description
It was reported that the patient inserted the coude intermittent catheter and felt resistance, the patient then reportedly went to remove the catheter and noticed blood coming out of the catheter as though the urethra had been cut.The patient noted that once the catheter was removed, it was noted that it had a sharp blunt end.The patient then reportedly inserted a new catheter and noticed blood in the urine which cleared up shortly afterwards.No medical intervention was reported.
Additional Manufacturer Narrative
The device was not returned for evaluation.A potential failure mode could be 'patient impact, tissue irritation during insertion¿ with a potential root cause of '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: ¿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.Visually inspect the product for any imperfections or surface deterioration prior to use." 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 that the patient inserted the coude intermittent catheter and felt resistance, the patient then reportedly went to remove the catheter and noticed blood coming out of the catheter as though the urethra had been cut.The patient noted that once the catheter was removed, it was noted that it had a sharp blunt end.The patient then reportedly inserted a new catheter and noticed blood in the urine which cleared up shortly afterwards.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: 8797739
• Report Number: 1018233-2019-03957
• Device Sequence Number: 16223502
• Product Code: KOD
• UDI-Device Identifier: 00801741038853
• UDI-Public: (01)00801741038853
• 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,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2019

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: 04/30/2021
• Device Model Number: 423710
• Device Catalogue Number: 423710
• Device Lot Number: NGCV2075
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/25/2019
• Supplement Date Received by Manufacturer: 09/03/2019
• Initial Report FDA Received Date: 07/17/2019
• Supplement Report FDA Received Date: 09/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1