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

Model Number	423714
Health Effect - Clinical Codes	No Patient Involvement (2645); 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 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.The device was not returned.
Event or Problem Description
It was reported that the catheter was twisted.
Additional Manufacturer Narrative
The reported event was confirmed.The visual evaluation of the returned sample noted four sealed vinyl intermittent catheters within the strip packs.All catheters appeared to be bent within the packaging and remained bent after they were removed.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: ¿for urological use only.To use: insert rounded end of catheter.Length bard and clean-cath are trademarks and/or registered trademarks of c.R.Bard, inc.Or an affiliate.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.Catheter manufactured in malaysia packaged in mexico".
Event or Problem Description
It was reported that the catheter was twisted.
Additional Manufacturer Narrative
The device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: ¿bard clean-cath length for urological use only sterile eo latex-free to use: insert rounded end of catheter rx only 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 bard and clean-cath are trademarks and/or registered trademarks of c.R.Bard, inc.Or an affiliate.Catheter manufactured and packaged in mexico".
Event or Problem Description
It was reported that the catheter was twisted.

• 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: 7679524
• Report Number: 1018233-2018-02732
• Device Sequence Number: 16472899
• 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: distributor,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/14/2019

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: 03/31/2020
• Device Model Number: 423714
• Device Catalogue Number: 423714
• Device Lot Number: NGCP3991
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2018
• Initial Date Received by Manufacturer: 06/20/2018
• Supplement Date Received by Manufacturer: 08/03/2018; 12/26/2018
• Initial Report FDA Received Date: 07/11/2018
• Supplement Report FDA Received Date: 08/24/2018; 01/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1