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

Model Number	0165L22
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/15/2022
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 balloon part was not full.The incident happened when it was on the patient.It was stated that post anesthesia care unit nurse checked the balloon, there was a hole in the balloon and it would not fill.As per additional information received via email on 21sep2022, it was stated that there was a patient involved and the harm was trauma with re-insertion of the catheter.The physician had to come back and insert another catheter.
Event or Problem Description
It was reported that the foley balloon part was not full.The incident happened when it was on the patient.It was stated that post anesthesia care unit nurse checked the balloon, there was a hole in the balloon and it would not fill.As per additional information received via email on (b)(6) 2022, it was stated that there was a patient involved and the harm was trauma with re-insertion of the catheter.The physician had to come back and insert another catheter.
Additional Manufacturer Narrative
The reported event is confirmed, cause unknown.The two way latex foley catheter was returned.Although a specific cause cannot be determined, a potential root cause for this event could be, "high modulus latex".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 states the following: "warning: on catheter, do not use ointments or lubricants having petrolatum base.They will damage latex and may cause the balloon to burst." "recommended inflation capacities 5cc balloon: use 10ml sterile water" "do not exceed recommended capacities." "should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient." "visually inspect the product for any imperfections or surface deterioration prior to use." correction- d, g, h 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 actual/suspected device was inspected.

• Brand Name: BARDEX® LUBRICATH® FOLEY CATHETER
• Common Device Name: 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: 15493989
• Report Number: 1018233-2022-07473
• Device Sequence Number: 1793081
• Product Code: EZC
• UDI-Device Identifier: 00801741017513
• UDI-Public: (01)00801741017513
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2023

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: 04/30/2026
• Device Model Number: 0165L22
• Device Catalogue Number: 0165L22
• Device Lot Number: NGGN0810
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/15/2022
• Supplement Date Received by Manufacturer: 02/24/2023
• Initial Report FDA Received Date: 09/27/2022
• Supplement Report FDA Received Date: 02/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown