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

Catalog Number	165810
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there had been multiple insertion issues with foley catheter.Per additional information received via email on 18jul2025, it was reported that the foley catheter inserted and inflated with 5ml sterile water of the balloon per manufacturer instruction.The foley catheter removed per surgical team.Foley catheter balloon deflated and removed 5mil of sterile water.There as a resistance when trying to removed the catheter.Informed to doctor and they tried to remove herself and removed successfully.Assessed the ureteral orifice, redness and no bleeding noted.The foley catheter tip with he balloon formed a ring around the catheter.The customer brought a defective bard foley silicone catheter 10 fr.Bardex165810.The catheter balloon does not fully deflate and forms a ring instead of collapsing against the sheath.It was reported that multiple nurses had experienced this with their patients but had not reported it.They cannot determine if other sizes of the catheters are also defective.The lots were identified lot#: ngjw3356, nggz1490, ngghw2036 and ngju2172.Per additional information received via phone on 25jul2025, it was reported that type of catheter failure stanford was experiencing and unfortunately, the lot number for the catheter shown as unknown, as the product was discarded.However, stanford identified four affected lots: ngjw3356, nggz1490, nghw2036, and ngju2172.All four were removed from inventory and discarded, and no samples are available for testing or evaluation.Customer was unable to confirm the type of syringe used.The patient impacted on one incident, a nurse applied lubricant to assist with catheter removal, and a small amount of blood was observed at the urethral opening.In another incident (described in the attached photo), the surgical team removed the foley catheter.Upon assessment, the urethral orifice appeared red but showed no signs of bleeding.No medical intervention was reported.
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.
Additional Manufacturer Narrative
The reported event was unconfirmed.Received 5 unopened all silicone foley catheters.Verified material numbers 165810,165808, 175806, 175812 and batch numbers nghq2675, ngjz1614, ngkr3556, ngjy2293, ngkq3811.Visual inspection noted no obvious observations.Ngjz1614: cath batch: ngkno0366.The catheter was filled with 5ml of methylene blue solution (3 drops 1% methylene blue per 100ml distilled water).Using in house syringe.The concentricity of the balloon was within specification.The balloon was able to passively deflate in 1min 13sec without cuffing noted.The reported event was unconfirmed.Ngkq3811: the catheter was filled with 1.5ml of methylene blue solution (3 drops 1% methylene blue per 100ml distilled water).Using in house syringe.The concentricity of the balloon was within specification.The balloon was able to passively deflate in 0min 42sec without cuffing noted.The reported event was unconfirmed.Ngjy2293: cath batch: ngjx2975.The catheter was filled with 10ml of methylene blue solution (3 drops 1% methylene blue per 100ml distilled water).Using in house syringe.The concentricity of the balloon was within specification.The balloon was able to passively deflate in 2min 46sec without cuffing noted.The reported event was unconfirmed.Ngkr3556: the catheter was filled with 1.5ml of methylene blue solution (3 drops 1% methylene blue per 100ml distilled water).Using in house syringe.The concentricity of the balloon was within specification.The balloon was able to passively deflate in 0min 25sec without cuffing noted.The reported event was unconfirmed.Nghq2675: cath batch: nggy5301.The catheter was filled with 5ml of methylene blue solution (3 drops 1% methylene blue per 100ml distilled water).Using in house syringe.The concentricity of the balloon was within specification.The balloon was able to passively deflate in 1min 07sec without cuffing noted.The reported event was unconfirmed.A device history record review was not required as the investigation was unconfirmed.Corrections made to tab(s) d and 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 there had been multiple insertion issues with foley catheter.Per additional information received via email on 18jul2025, it was reported that the foley catheter inserted and inflated with 5ml sterile water of the balloon per manufacturer instruction.The foley catheter removed per surgical team.Foley catheter balloon deflated and removed 5ml of sterile water.There as a resistance when trying to removed the catheter.Informed to doctor and they tried to remove herself and removed successfully.Assessed the ureteral orifice, redness and no bleeding noted.The foley catheter tip with he balloon formed a ring around the catheter.The customer brought a defective bard foley silicone catheter 10 fr.Bardex165810.The catheter balloon does not fully deflate and forms a ring instead of collapsing against the sheath.It was reported that multiple nurses had experienced this with their patients but had not reported it.They cannot determine if other sizes of the catheters are also defective.The lots were identified lot#ngjw3356, nggz1490, ngghw2036, ngju2172.Per additional information received via phone on 25jul2025, it was reported that type of catheter failure (b)(6) was experiencing and unfortunately, the lot number for the catheter shown as unknown, as the product was discarded.However, (b)(6) identified four affected lots: ngjw3356, nggz1490, nghw2036, and ngju2172.All four were removed from inventory and discarded, and no samples are available for testing or evaluation.Customer was unable to confirm the type of syringe used.The patient impacted on one incident, a nurse applied lubricant to assist with catheter removal, and a small amount of blood was observed at the urethral opening.In another incident (described in the attached photo), the surgical team removed the foley catheter.Upon assessment, the urethral orifice appeared red but showed no signs of bleeding.No medical intervention was reported.

• Brand Name: BABARDEX® PEDIATRIC 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, GA 30014 ; 7707846100
• MDR Report Key: 22666894
• Report Number: 1018233-2025-06305
• Device Sequence Number: 19752380
• Product Code: KOD
• UDI-Device Identifier: 00801741029721
• UDI-Public: (01)00801741029721(11)230503(17)271031(10)NGHQ2675
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K821745
• 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
• Report Date (Section B): 04/02/2026

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: 165810
• Device Lot Number: NGHQ2675
• 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: 07/25/2025
• Supplement Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2023
• 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: Female