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

Model Number	421614
Medical Device Problem Code	Misassembled (1398)
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.
Event or Problem Description
It was reported that the catheters were loaded into the packaging backwards.The patient advised that when he opened the package he had to touch the entire catheter to get the insertion side.The patient reported that he did not use the product due to the fear of infection.
Event or Problem Description
It was reported that the catheters were loaded into the packaging backwards.The patient advised that when he opened the package he had to touch the entire catheter to get the insertion side.The patient reported that he did not use the product due to the fear of infection.
Additional Manufacturer Narrative
The reported event was confirmed manufacturing related since the packaging was done by the manufacturer.Visual evaluation of the returned sample noted five clean cath intermittent catheters within the original packaging.The catheters were all noted to be packaged with the tips pointing away from the chevron end.A catheter without the tip in the chevron seal is out of specification.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: ¿visually inspect the product for any imperfections or surface deterioration prior to use.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.".

• Brand Name: BARD® CLEAN-CATH® CATHETER
• Common Device Name: VINYL STRAIGHT CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8290157
• Report Number: 1018233-2019-00496
• Device Sequence Number: 13858017
• Product Code: KOD
• UDI-Device Identifier: 00801741038976
• UDI-Public: (01)00801741038976
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 05/09/2019

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: 10/31/2023
• Device Model Number: 421614
• Device Catalogue Number: 421614
• Device Lot Number: NGCX4086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2019
• Initial Date Received by Manufacturer: 01/07/2019
• Supplement Date Received by Manufacturer: 04/23/2019
• Initial Report FDA Received Date: 01/30/2019
• Supplement Report FDA Received Date: 05/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1