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

Model Number	423712
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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 that patient stated there was some loose catheters that were thrown in the box which they were twisted and bent.Also stated these were not soft catheters.
Event or Problem Description
It was reported that the patient stated there was some loose catheters that were thrown in the box which they were twisted and bent.Also stated these were not soft catheters.
Additional Manufacturer Narrative
The reported event was inconclusive, as no sample returned for evaluation.A potential root cause for this failure mode could be due to ¿inappropriate package design.¿ it was unknown whether the device had met specifications.The product used for the treatment purposes.It was unknown whether the product had caused the reported failure.The device was not returned for evaluation.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: "for urological use only.To use: insert rounded end of catheter.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.Do not reuse.Do not resterilize.Do not use if package is damaged.Visually inspect the product for any imperfections or surface deterioration prior to use.".

• 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: 10382192
• Report Number: 1018233-2020-05066
• Device Sequence Number: 19555347
• Product Code: KOD
• UDI-Device Identifier: 00801741038860
• UDI-Public: (01)00801741038860
• 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): 08/26/2020

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: 423712
• Device Catalogue Number: 423712
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/17/2020
• Supplement Date Received by Manufacturer: 08/14/2020
• Initial Report FDA Received Date: 08/07/2020
• Supplement Report FDA Received Date: 08/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1