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

Model Number 123520A

Device Problem Burst Container or Vessel (1074)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/31/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that the catheter balloon was found to be broken before placing.Customer replaced with new products.

Event Description

It was reported that the catheter balloon was found to be broken before placing.Customer replaced with new products.

Manufacturer Narrative

The reported event was confirmed and 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 the balloon catheter could have burst causing leak.However, the potential root cause for this failure mode could be user related (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: "uses: to be used as the drainage of urine from the bladder for the children and adults.Warnings: - do not use petroleum substrate lubricants with the latex-based urethral cathethers such as petroleum jelly and label liquid paraffin which will damage latex and cause burst balloon.- do not aspirate urine through the drainage funnel wall.- single use only.Do not re-sterlize.- for urological use only." corrections: d,h 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.H3 other text : photo sample received.

• Brand Name: BARDIA FOLEY CATHETER SILICONE COATED
• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11229332
• MDR Text Key: 228995172
• Report Number: 1018233-2021-00122
• Device Sequence Number: 1
• Product Code: EZC
• UDI-Device Identifier: 00801741095115
• UDI-Public: (01)00801741095115
• Combination Product (y/n): N
• PMA/PMN Number: K910846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/21/2021

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
• Device Operator: Health Professional
• Device Model Number: 123520A
• Device Catalogue Number: 123520A
• Device Lot Number: MYEN1840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2021
• Initial Date Manufacturer Received: 01/06/2021
• Initial Date FDA Received: 01/26/2021
• Supplement Dates Manufacturer Received: 05/21/2021
• Supplement Dates FDA Received: 06/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other