MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX®LUBRICATH® FOLEY CATHETER ALCOCK MODEL; FOLEY CATHETER (LATEX)

Model Number	0134L20
Medical Device Problem Code	Misassembled (1398)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/02/2019
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 foreign material was found on the catheter when the package was opened.Per email received from the ibc representative on 7-jan-2020, the catheter drainage eyes were found to be to far from the catheter tip.
Additional Manufacturer Narrative
The reported event was confirmed.An amber irrigation lubricath catheter was returned opened with its original packaging (gross visual evaluation).The drainage eye measurements were taken.The tip length of the upper eye was above specifications.The root cause of this failure was an operator error during drainage eye burning.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.".
Event or Problem Description
It was reported that foreign material was found on the catheter when the package was opened.It was later reported from the international business center representative on (b)(6) 2020, the catheter drainage eyes were found to be to far from the catheter tip.

• Brand Name: BARDEX®LUBRICATH® FOLEY CATHETER ALCOCK MODEL
• Common Device Name: FOLEY CATHETER (LATEX)
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9644425
• Report Number: 1018233-2020-00616
• Device Sequence Number: 3129505
• Product Code: KOD
• UDI-Device Identifier: 00801741018763
• UDI-Public: (01)00801741018763
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K922431
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2020

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: Health Professional
• Device Expiration Date: 09/20/2023
• Device Model Number: 0134L20
• Device Catalogue Number: 0134L20
• Device Lot Number: NGCZ2425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2020
• Initial Date Received by Manufacturer: 01/07/2020
• Supplement Date Received by Manufacturer: 03/26/2020
• Initial Report FDA Received Date: 01/29/2020
• Supplement Report FDA Received Date: 04/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1