MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER

Catalog Number 175816

Device Problem Material Fragmentation (1261)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/07/2023

Event Type  Injury  

Event Description

It was reported that foley tray had report of adverse event.No other particulars indicated.(batch#nghq2185 , batch#nggz1611 and batch#nghg1002).Per follow up via phone on 17 aug 2023, contact stated that the foley fell out of the patient and the nurse noticed that the tip was missing.Patient had to gone through surgery to check the bladder for the tip.Contact was retrieving additional information on the surgery and status of patient and would return call 18 aug 2023.Per follow up via phone on 23 aug 2023, contact stated that it was believed that the foley might have broken in the bladder.The patient was taken into surgery, but nothing else was found in the bladder/patient and no additional issues were found.Patient recovered from surgery with no further problems.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all 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 bd.H3 other text : the device was not returned.

Manufacturer Narrative

The reported event was inconclusive because no sample was available for evaluation and further investigation did not result in any additional findings.Although a root cause could not be definitively identified, based on the risk documentation review, a potential root cause for this type of failure could be ¿silicone too weak to withstand normal forces applied during use".However, there was insufficient information to confirm this potential root cause.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.If package is opened or if any imperfection or surface deterioration is observed, do not use." h11: section a through f - the information provided by bd represents all 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 bd.

Event Description

It was reported that foley tray had report of adverse event.No other particulars indicated.(batch#nghq2185 , batch#nggz1611 and batch#nghg1002).Per follow up via phone on 17aug2023, contact stated that the foley fell out of the patient and the nurse noticed that the tip was missing.Patient had to gone through surgery to check the bladder for the tip.Contact was retrieving additional information on the surgery and status of patient and would return call 18aug2023.Per follow up via phone on 23aug2023,contact stated that it was believed that the foley might have broken in the bladder.The patient was taken into surgery, but nothing else was found in the bladder/patient and no additional issues were found.Patient recovered from surgery with no further problems.

• Brand Name: BARDEX® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER
• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 17714225
• MDR Text Key: 323001402
• Report Number: 1018233-2023-06685
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741034169
• UDI-Public: (01)00801741034169
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 175816
• Device Lot Number: NGGZ1611
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/17/2023
• Initial Date FDA Received: 09/08/2023
• Supplement Dates Manufacturer Received: 09/11/2023
• Supplement Dates FDA Received: 05/24/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/12/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention