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

Model Number	123520A
Medical Device Problem Codes	Calcified (1077); Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/05/2022
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 catheter was removed today due to a patient report of leaking.The catheter was due to be changed on or around (b)(6) 2022.Therefore, the patient requested a new catheter to be inserted.Upon removal of the old catheter, a substance pale yellow in color landed on the patient's vulva.Upon inspection, the material was hard and non-palpable.When squeezed, it broke into 3 pieces, and the clinician closely examined the tip and deflated balloon of the catheter.Upon visual and tactile inspection, the clinician noted that when the tip of the catheter was squeezed or lightly scraped with a gloved finger, particles were dislodging from the catheter and appeared to be catheter material dislodging from the catheter.No medical intervention was reported.
Additional Manufacturer Narrative
The reported event was inconclusive because poor sample condition.Based on the attached photos, it was observed that there were a few fragment of unknown particle on the catheter surface.However, it is unknown whether the fragments was also exist on the other area of catheter shaft since the photo only focus on the distal area.A complete evaluation could not be performed and unable to perform functional testing due to poor sample condition.The potential root cause for this failure mode could be due to total solids too low/chain speed too fast/stirring too fast/old coating solution/no catalyst added/high humidity/insufficient coating/curing time cause coating peel off.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: "bardia foley catheter caution: this product contains natural rubber latex which may cause allergic reactions.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.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.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.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.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." correction: d,f,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.
Event or Problem Description
It was reported that the foley catheter was removed today due to a patient report of leaking.The catheter was due to be changed on or around (b)(6) 2022.Therefore, the patient requested a new catheter to be inserted.Upon removal of the old catheter, a substance pale yellow in color landed on the patient's vulva.Upon inspection, the material was hard and non-palpable.When squeezed, it broke into 3 pieces, and the clinician closely examined the tip and deflated balloon of the catheter.Upon visual and tactile inspection, the clinician noted that when the tip of the catheter was squeezed or lightly scraped with a gloved finger, particles were dislodging from the catheter and appeared to be catheter material dislodging from the catheter.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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 15680978
• Report Number: 1018233-2022-08157
• Device Sequence Number: 20444074
• Product Code: EZC
• UDI-Device Identifier: 00801741095115
• UDI-Public: (01)00801741095115
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2022

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: 123520A
• Device Catalogue Number: 123520A
• Device Lot Number: MYFY5300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/14/2022
• Supplement Date Received by Manufacturer: 12/23/2022
• Initial Report FDA Received Date: 10/27/2022
• Supplement Report FDA Received Date: 12/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2022
• 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