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

Model Number	123512A
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	03/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the foley catheter was inserted on (b)(6) 2023.On (b)(6) 2023, the nurse discovered that the catheter was dislodged during routine care.The catheter was inspected, the balloon was complete but burst.As per the photo sample received, it was found that the catheter balloon was burst.Stated that the user was exposed to blood, or bodily fluids and the detailed exposure was urine.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Additional Manufacturer Narrative
The reported event was confirmed ¿ cause unknown.The reported failure was able to be reproduced.The product was used for urological care.Based on the attached photo, it was observed that there was sac burst along lumen.However, no functional testing could not be performed since there are only photo provided for investigation.The exact cause of how and when the problem occurred could not be determined.Potential root cause for this failure mode could be short latex dwell time, latex dip speed out too slow causing thin sac and also could be contributed by the user itself (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: "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 burst.Do not aspirate urine through the drainage funnel wall.Single patient use only.Do not reuse and resterilize.For urological use only.Use luer slip syringe.Do not use needle.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.If permitted by hospital protocol, the may be cut off.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 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.The actual/suspected device was evaluated.
Event or Problem Description
It was reported that the foley catheter was inserted on (b)(6) 2023.On 19th march 2023, the nurse discovered that the catheter was dislodged during routine care.The catheter was inspected, the balloon was complete but burst.As per the photo sample received, it was found that the catheter balloon was burst.Stated that the user was exposed to blood, or bodily fluids and the detailed exposure was urine.It was unknown what medical intervention was provided.

• 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 16724062
• Report Number: 1018233-2023-02481
• Device Sequence Number: 12565156
• Product Code: EZC
• UDI-Device Identifier: 00801741095078
• UDI-Public: (01)00801741095078
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2023

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 Expiration Date: 04/28/2025
• Device Model Number: 123512A
• Device Catalogue Number: 123512A
• Device Lot Number: MYEU2653
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/23/2023
• Supplement Date Received by Manufacturer: 05/24/2023
• Initial Report FDA Received Date: 04/12/2023
• Supplement Report FDA Received Date: 05/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/11/2020
• 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