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

Model Number	123624A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Skin Inflammation/ Irritation (4545); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.It was unknown whether the device had met relevant specifications.The product was used for urological care.It was unknown whether the product had caused the reported failure.The potential root cause for this failure could be user related (example: salt accumulation)/block drainage lumen/no drainage eye).The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: ¿caution: this product contains natural rubber latex which may cause allergic reactions.Sterile unless 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.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.Single patient use only.Do not reuse.Do not resterilize.For urological use only.Valve type: use luer syringe.Do not use needle.Visually inspect the product for any imperfections or surface deterioration prior to use.Do not use if package is opened or damaged.Recommended inflation capacities.5cc balloon: use 10cc sterile water.30cc balloon: use 35cc 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.¿ the device was not returned.
Event or Problem Description
It was reported that the foley catheter was defective because the patient was waking up wet.It was stated that the patient could not afford to get wet because of the previous wound.It was noted that the patient had been using the product for more than 90 days.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.The potential root cause for this failure could be user related (example: salt accumulation)/block drainage lumen/no drainage eye).The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: ''caution: this product contains natural rubber latex which may cause allergic reactions.Sterile unless 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.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.Single patient use only.Do not reuse.Do not resterilize.For urological use only.Valve type: use luer syringe.Do not use needle.Visually inspect the product for any imperfections or surface deterioration prior to use.Do not use if package is opened or damaged.Recommended inflation capacities 5cc balloon: use 10cc sterile water.30cc balloon: use 35cc 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.'' 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 foley catheter was defective because the patient was waking up wet.It was stated that the patient could not afford to get wet because of the previous wound.It was noted that the patient had been using the product for more than 90 days.Per follow up on (b)(6) 2022, it was reported that the patient had two foley catheters that would leak for an unknown reason.Stated that the customer was concerned with patient about wet from the catheters due to previous wounds that have healed being irritated again from the wetness.No medical intervention was reported.

• Brand Name: BARDIA® FOLEY CATHETER SILICONE COATED
• 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 12892086
• Report Number: 1018233-2021-07583
• Device Sequence Number: 4588994
• Product Code: KOD
• UDI-Device Identifier: 00801741095238
• UDI-Public: (01)00801741095238
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K922431
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Study,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2022

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 Model Number: 123624A
• Device Catalogue Number: 123624A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/05/2021
• Supplement Date Received by Manufacturer: 01/14/2022
• Initial Report FDA Received Date: 11/30/2021
• Supplement Report FDA Received Date: 02/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Male