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

Model Number	087016
Medical Device Problem Code	Partial Blockage (1065)
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.
Event or Problem Description
It was reported that the foley catheter prematurely deflated upon removal from the patient.The complainant advised that 'saline" was used to inflate the foley.The complainant advised via email on 23-april-2019 that she was mistaken about the use of saline and that the foley was inflated with sterile water.Per evaluation it was found on 12-july-2019 that the catheter inflation lumen had a blockage.
Additional Manufacturer Narrative
The reported event was confirmed.A latex foley catheter was returned.Methylene blue in inserted into the inflation lumen using a slip tip syringe in an attempt to find the occlusion.There was one occlusion about an inch from the balloon.The shaft was cut behind the occlusion and the balloon still did not deflate.The shaft was then cut even closer to the balloon until the balloon deflated.The final occlusion was right next to the balloon.The potential root cause could be due to a kinked lumen or foreign material.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 the foley catheter prematurely deflated upon removal from the patient.The complainant advised that 'saline" was used to inflate the foley.The complainant advised via email on (b)(6) 2019 that she was mistaken about the use of saline and that the foley was inflated with sterile water.

• Brand Name: BARDEX® LUBRICATH® FOLEY CATHETER EDELMAN MODEL
• Common Device Name: COATED CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8848210
• Report Number: 1018233-2019-04388
• Device Sequence Number: 11445799
• Product Code: EZC
• UDI-Device Identifier: 00801741039232
• UDI-Public: (01)00801741039232
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K910846
• 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): 08/20/2019

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: Health Professional
• Device Expiration Date: 09/23/2023
• Device Model Number: 087016
• Device Catalogue Number: 087016
• Device Lot Number: MCCW3767
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2019
• Initial Date Received by Manufacturer: 07/12/2019
• Supplement Date Received by Manufacturer: 08/08/2019
• Initial Report FDA Received Date: 07/31/2019
• Supplement Report FDA Received Date: 08/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1