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

Model Number	366714
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	Urinary Retention (2119)
Date of Event	06/26/2023
Type of Reportable Event	Serious Injury
Additional 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.
Event or Problem Description
It was reported that the customer was climbing through a fence on sunday evening and heard a pop noise.Shortly after, the customer's foley catheter had fallen out.The customer examined same and found the balloon on the end of the catheter had ruptured.The customer then phoned the home care office the next morning and reported same to the home care nurse.The customer came to the office and had same reinserted.No apparent harm reached the patient.The impact of the incident was patient was unable to void.The patient required unexpected or prolonged care.
Event or Problem Description
It was reported that the customer was climbing through a fence on sunday evening and heard a pop noise.Shortly after, the customer's foley catheter had fallen out.The customer examined same and found the balloon on the end of the catheter had ruptured.The customer then phoned the home care office the next morning and reported same to the home care nurse.The customer came to the office and had same reinserted.No apparent harm reached the patient.The impact of the incident was patient was unable to void.The patient required unexpected or prolonged care.
Additional Manufacturer Narrative
The reported event was confirmed and the cause was unknown.The potential root cause for this failure could be user related (example: contact with sharp object)/ exposure to petrolatum based products/ mechanical failure/operator error).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: "do not use ointments or lubricants having a petrolatum base.They will damage latex and may burst balloon." h11: section a through f - the information provided by bard represents all of 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 bard.H3 other text : the actual/suspected device was inspected.

• Brand Name: BARD® 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: 17370638
• Report Number: 1018233-2023-05390
• Device Sequence Number: 3784595
• Product Code: KOD
• UDI-Device Identifier: 00801741077838
• UDI-Public: (01)00801741077838
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K922431
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2023

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
• Operator of Device: Health Professional
• Device Model Number: 366714
• Device Catalogue Number: 366714
• Device Lot Number: MYGQ6687
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2023
• Supplement Date Received by Manufacturer: 08/22/2023
• Initial Report FDA Received Date: 07/21/2023
• Supplement Report FDA Received Date: 08/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2022
• 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