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

Catalog Number	366714
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Codes	Discomfort (2330); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2023
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.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 tip of the foley catheter was sitting along the inside aspect of thigh, had come out of bladder.On closer inspection, there was an incision like separation in the balloon of the catheter that caused the balloon to collapse and the catheter to come out of the bladder.New catheter had to be reinserted into bladder.They did not report having any pain or discomfort at time of inspection or new catheter insertion.New catheter was draining clear amber urine.
Additional Manufacturer Narrative
The reported event was confirmed ¿ cause unknown.Based on the attached photo, it was observed that the balloon was burst.However, the exact cause of how and when the problem occurred could not be determined.No further testing could be conducted due to only photo sample is provided.A potential root cause for this failure could be for this failure mode could be user related (example: contact with sharp object/ exposure to petrolatum based products mechanical failure/operator error).A potential root cause for this failure mode could be low latex viscosity, short latex dwell time, latex dip speed out too slow causing thin sac.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.The instructions for use were found adequate and state the following: "sterile unless package is opened or damaged.Do not use if package is opened or damaged.Warning: on catheter, do not use ointments or lubricants having a petrolatum base.They will damage latex and may cause balloon to burst.Caution: do not aspirate urine through drainage funnel wall.Storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.Note: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable laws and regulations.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Valve type: use luer syringe.Do not use needle.Visually inspect the product for any imperfections or surface deterioration prior to use.Recommended inflation capacities: 3cc balloon: use 5cc sterile water.5cc balloon: use 10cc sterile water.15cc balloon: use 20cc sterile water.20cc balloon: use 25cc sterile water.30cc balloon: use 35cc sterile water.40cc balloon: use 45cc sterile water.75cc balloon: use 80cc sterile water.Do not exceed recommended capacities.To deflate catheter balloon: gently insert a syringe in the catheter valve.Never use more force than is required to make the syringe ¿stick¿ in the valve.If you notice slow or no deflation, re-seat the syringe gently.Use only gentle aspiration to encourage deflation if needed.Vigorous aspiration may collapse the inflation lumen, preventing balloon deflation.If permitted by hospital protocol, the valve arm may be severed.If this fails, contact an adequately trained professional for assistance, as directed by hospital protocol.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient." 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 tip of the foley catheter was sitting along the inside aspect of thigh (had come out of bladder).On closer inspection, there was an incision like separation in the balloon of the catheter that caused the balloon to collapse and the catheter to come out of the bladder.New catheter had to be reinserted into bladder.They didn't report having any pain or discomfort at time of inspection or new catheter insertion.New catheter was draining clear amber urine.

• 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: 18562196
• Report Number: 1018233-2024-00205
• Device Sequence Number: 6595180
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2024

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: 366714
• Device Lot Number: MYGS0127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2024
• Supplement Date Received by Manufacturer: 02/07/2024
• Initial Report FDA Received Date: 01/23/2024
• Supplement Report FDA Received Date: 02/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/07/2022
• 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