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

Catalog Number	175808
Medical Device Problem Codes	Material Rupture (1546); Sharp Edges (4013)
Health Effect - Clinical Code	Distress (2329)
Date of Event	09/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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 bard foley catheter tray 8fr pediatric kit was used for a routine voiding cystourethrogram under fluoroscopy.Insertion was without issue and functioned correctly during the examination.Foley catheter balloon was appropriately deflated with removal of at least 5 cc of fluid.During the removal of the catheter, however, significant resistance was met at the navicular fossa or meatus portion.The patient was in distress as a result.Reinsertion was also met with resistance.The pediatric intensive care unit nursing team who facilitated the placement was consulted and they also became uncomfortable with the degree of resistance.Contrast was administered and confirmed in imaging a normal course of urethra and well as a deflated balloon.The urology team was then consulted who then removed the catheter against the resistance.No blood or trauma was noted following the removal.The urology team noted a design flaw distal to the foley balloon in which there were plastic prongs that were caught within the urethra.The physician and them examined an unopened kit different lot from stock and noted no reproduction of prongs distal to the balloon.It was unknown what medical intervention was provided.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was available for evaluation and further investigation did not result in any additional findings.No actions can be taken at this time since a root cause was not identified.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.The instructions for use were found adequate and state the following: visually inspect the product for any imperfections or surface deterioration prior to use.If package is opened or if any imperfection or surface deterioration is observed, do not use.Foley catheter removal: 5.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient.Correction: d 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 bard foley catheter tray 8fr pediatric kit was used for a routine voiding cystourethrogram under fluoroscopy.Insertion was without issue and functioned correctly during the examination.Foley catheter balloon was appropriately deflated with removal of at least 5 cc of fluid.During the removal of the catheter, however, significant resistance was met at the navicular fossa or meatus portion.The patient was in distress as a result.Reinsertion was also met with resistance.The pediatric intensive care unit nursing team who facilitated the placement was consulted and they also became uncomfortable with the degree of resistance.Contrast was administered and confirmed in imaging a normal course of urethra and well as a deflated balloon.The urology team was then consulted who then removed the catheter against the resistance.No blood or trauma was noted following the removal.The urology team noted a design flaw distal to the foley balloon in which there were plastic prongs that were caught within the urethra.The physician and them examined an unopened kit different lot from stock and noted no reproduction of prongs distal to the balloon.It was unknown what medical intervention was provided.Per additional information received via email on 08nov2024, it was reported that a bard 16fr foley catheter was placed in a patient here in micu by the overnight nurse around 6am.A few hours later the day nurse found the foley laying in the bed.The nurse was concerned for the reason the foley was out and flushed to check the balloon and the balloon was not intact.They saved the foley but not the packaging but the lot number for the 16fr bard kit in the back was ngjt3648.No harm to patient due to active recovery efforts of nursing.
Additional Manufacturer Narrative
The reported event was confirmed cause unknown.Visual evaluation of the returned sample noted one opened (without original packaging), used silicone foley.Visual inspection of the sample noted 1 two-way foley catheter with balloon rupture (measuring 0.2965") on the return sample.No missing pieces were noted.Based on the results of the investigation, no actions can be taken at this time since a root cause was not identified.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.The instructions for use were found adequate and states the following: visually inspect the product for any imperfections or surface deterioration prior to use.If package is opened or if any imperfection or surface deterioration is observed, do not use.Foley catheter removal: should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient.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 bard foley catheter tray 8fr pediatric kit was used for a routine voiding cystourethrogram under fluoroscopy.Insertion was without issue and functioned correctly during the examination.Foley catheter balloon was appropriately deflated with removal of at least 5 cc of fluid.During the removal of the catheter, however, significant resistance was met at the navicular fossa or meatus portion.The patient was in distress as a result.Reinsertion was also met with resistance.The pediatric intensive care unit nursing team who facilitated the placement was consulted and they also became uncomfortable with the degree of resistance.Contrast was administered and confirmed in imaging a normal course of urethra and well as a deflated balloon.The urology team was then consulted who then removed the catheter against the resistance.No blood or trauma was noted following the removal.The urology team noted a design flaw distal to the foley balloon in which there were plastic prongs that were caught within the urethra.The physician and them examined an unopened kit different lot from stock and noted no reproduction of prongs distal to the balloon.It was unknown what medical intervention was provided.Per additional information received via email on (b)(6)2024, it was reported that a bard 16fr foley catheter was placed in a patient here in micu by the overnight nurse around 6am.A few hours later the day nurse found the foley laying in the bed.The nurse was concerned for the reason the foley was out and flushed to check the balloon and the balloon was not intact.They saved the foley but not the packaging but the lot number for the 16fr bard kit in the back was ngjt3648.No harm to patient due to active recovery efforts of nursing.

• Brand Name: BARDEX® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER
• Common Device Name: SILICONE 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: 20266531
• Report Number: 1018233-2024-05904
• Device Sequence Number: 3470217
• Product Code: EZL
• UDI-Device Identifier: 00801741029370
• UDI-Public: (01)00801741029370(11)240327(17)250731(10)NGJP3130
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K984084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/10/2025

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: 07/31/2025
• Device Catalogue Number: 175808
• Device Lot Number: NGJP3130
• 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: 09/04/2024
• Supplement Date Received by Manufacturer: 11/15/2024; 01/11/2025
• Initial Report FDA Received Date: 09/20/2024
• Supplement Report FDA Received Date: 11/25/2024; 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/2024
• 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; Required Intervention
• Patient Sex: Unknown