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

Catalog Number	806514
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2025
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.Udi format updated with available product information per gudid.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 foley catheter had a pin hole at the y connector.Saline was coming out.Lot#ngjw3118.Foley catheter balloon would not deflate lot#ngjt2607.Balloon would not deflate lot#ngjs5070.
Additional Manufacturer Narrative
The reported event was unconfirmed.Visual evaluation of the returned sample noted three opened (without original packaging), used silicone foley.Visual inspection of the second sample noted using the (in-house) syringe the catheter balloon was inflated with 10 ml methylene blue solution (3 drops 1 percentage aq methylene blue per 100ml distilled water) and inflated passively with no issues.With the (in-house) syringe attached the balloon deflated with no difficulties.The reported event could not be replicated.No root cause could be found because the reported event was unconfirmed.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.The reported event is unconfirmed, a labeling review is not required.Correction: d, e, h udi format updated with available product information per gudid.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 foley catheter had a pin hole at the y connector.Saline was coming out.Lot # ngjw3118.Foley catheter balloon would not deflate.Lot # ngjt2607.Balloon would not deflate lot# ngjs5070.Per customer via email on 04mar2025, it was reported that lot # ngjw3118 item # 806514 customer stated that the bard foley had a pinhole in it at the y connector.Saline was came out.They went to test the foley securement, and it came out.Balloon was deflated.Lot# for the affected 2, 1 with balloon would not deflate.Lot# ngjs5070.Or lot# ngjt2607.Not sure what package either foley was pulled out of.The other one that customer did not know what was wrong with it was the 5070 lot.

• Brand Name: BARDIA® ALL-SILICONE FOLEY CATHETER
• Common Device Name: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 21333373
• Report Number: 1018233-2025-00674
• Device Sequence Number: 7865844
• Product Code: GBM
• UDI-Device Identifier: 00801741039164
• UDI-Public: (01)00801741039164(11)240721(17)281130(10)NGJT2607
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K760093
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2025

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: 806514
• Device Lot Number: NGJT2607
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2025
• Supplement Date Received by Manufacturer: 08/26/2025
• Initial Report FDA Received Date: 02/07/2025
• Supplement Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2024
• 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