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

Catalog Number	806512
Medical Device Problem Codes	Burst Container or Vessel (1074); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient put the foley catheter in and when the patient moved it fell out, they looked at the balloon and it looked ruptured.Customer would like a replacement for the foley and the tray.
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 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 bd.
Additional Manufacturer Narrative
The reported event is confirmed cause unknown.Visual evaluation noted visual inspection of the sample noted 1 two-way foley catheter with balloon burst (measuring 0.2045) on the return sample.No missing pieces were noted.Received 1 photo sample of bard medical document.Based on physical sample received product does not meet specifications which states "pinholes are not permitted." although an exact root cause could not be determined a potential root cause could be pinhole in balloon or cuff.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: "caution: fda law restricts this device to sale by or on the order of physician.Sterile: unless package is opened or damaged.Warning: do not use ointments or lubricant's having a petroleum based, they will damage silicone and may cause balloon to burst.To deflate the catheter balloon.Gently insert a syringe in the catheter valve.Never use more force than is required to make the syringe "stick" is the valve.If you notice slow or no deflation, re-insert the syringe gently.Should balloon rupture occur, care should be taken to assure that all balloon fragment's have been from the patient.Visually inspect the product for any imperfections or surface deterioration prior to use." h11:section a through f - the information provided by bd 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 bd.
Event or Problem Description
It was reported that the patient put the foley catheter in and when the patient moved it fell out, they looked at the balloon and it looked ruptured.Customer would like a replacement for the foley and the tray.Per follow up information received via mail on 11dec2023, stated that the foley catheter was used on the patient and the foley was inserted and the balloon was inflated but after 5 minutes the foley catheter fell out.Per sample form received on 12dec2023, it was stated that the patient was laying, foley catheter was placed and attached to the leg bag, patient rolled on their side, urine leaked.Upon checking, foley was found not intact and replaced.No medical intervention was required.Per follow up information received via mail on 14dec2023, the missing pieces found inside the patient was unknown.They did not go to the hospital.They just put another foley in.

• Brand Name: BARDIA® ALL-SILICONE 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: 18256859
• Report Number: 1018233-2023-08715
• Device Sequence Number: 7059522
• Product Code: EZL
• UDI-Device Identifier: 00801741072925
• UDI-Public: (01)00801741072925
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K040504
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2024

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 Catalogue Number: 806512
• Device Lot Number: NGGX4641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2023
• Supplement Date Received by Manufacturer: 03/06/2024
• Initial Report FDA Received Date: 12/04/2023
• Supplement Report FDA Received Date: 03/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2023
• 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 Age: 19 YR
• Patient Sex: Female
• Patient Weight: 40 KG