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

Catalog Number	73020L
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2025
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.This report references a us equivalent device.The us udi equivalent for this product number is used.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 the customer contacted regarding a material safety report concerning foley silicone 3-way ch18 probes, reference (b)(4), batch nghq0771.The problem raised occurred on two occasions, a patient was catheterized with a catheter for bladder lavage.The catheter did not stay in place and the balloon was found to be deflated and leaking after removal.This led to several catheterizations, which ended up being traumatic.On the other hand, the patient had no particular obstacle, and there were no handling problems as nurse who had already performed the procedure, doctor present, patient cooperative (lot# nghq0771) and (lot# unk).A new incident occurred again with the same patient with a 3v ch20 probe, reference (b)(4) and did not have a sample for this probe (lot# nghp0228) and (lot# unk).Per follow up information received via ibc on (b)(6) 2025, the patient had to be treated again, which became traumatic.The procedure was uncomfortable and causes a loss of time and stress.The event occurred first time was on (b)(6) 2025, and the second time was shortly afterwards on the same day.The two probes that became misaligned were discarded by the department.However, have several new probes from the same batch in possession, which could be send.There were 13 unused sample and used product not kept and cannot send them (b)(4) and stated that the probe became misaligned and had to be replaced, the date of event was (b)(6) 2025, the lot number was nghp0228.The sample in question has not been kept, but they had new probes from the same batch in stock, which they can also send.No photos were sent to them (b)(4).
Additional Manufacturer Narrative
The reported event was unconfirmed.Visual evaluation of the returned sample noted two unopened (with original packaging), silicone foley with two batch numbers (nggp0098 & nggs1185).Visual inspection of the sample noted that using the (in-house) syringe the catheter balloon (nggp0098) was inflated with 30 ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water) and inflated properly with the balloon being symmetrical.With the syringe attached the balloon passively deflated within 1 min 37 seconds with no cuffing.No root cause could be found because the reported event was unconfirmed.As the reported event is unconfirmed, a risk review is not required.As the reported event is unconfirmed, a labeling review is not required.A device history record review was not required as the investigation was unconfirmed.The investigation is concluded, and no additional action is required at this time.Corrections: d, e, h.This report references a us equivalent device.The us udi equivalent for this product number is used.H11: sections 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 the customer contacted regarding a material safety report concerning foley silicone 3-way ch18 probes, reference (b)(4), batch nghq0771.The problem raised occurred on two occasions, a patient was catheterized with a catheter for bladder lavage.The catheter did not stay in place, and the balloon was found to be deflated and leaking after removal.This led to several catheterizations, which ended up being traumatic.On the other hand, the patient had no particular obstacle, and there were no handling problems as nurse who had already performed the procedure, doctor present, patient cooperative for (lot# nghq0771) and (lot# unk).A new incident occurred again with the same patient with a 3v ch20 probe, reference (b)(4) and did not have a sample for this probe (lot# nghp0228) and (lot# unk).Per follow up information received via ibc on (b)(6) 2025, the patient had to be treated again, which became traumatic.The procedure was uncomfortable and causes a loss of time and stress.The event occurred first time was on (b)(6) 2025, and the second time was shortly afterwards on the same day.The two probes that became misaligned were discarded by the department.However, have several new probes from the same batch in possession, which could be send.There were 13 unused sample and used product not kept and cannot send them (pcn# (b)(4)) and stated that the probe became misaligned and had to be replaced, the date of event was 31may2025, the lot number was nghp0228.The sample in question has not been kept, but they had new probes from the same batch in stock, which they can also send.No photos were sent to them (pcn# (b)(4)).
Additional Manufacturer Narrative
The reported event was unconfirmed.Visual evaluation of the returned sample noted two unopened (with original packaging), silicone foley with two batch numbers (nggp0098 & nggs1185).Visual inspection of the sample noted that using the (in-house) syringe the catheter balloon (nggp0098) was inflated with 30 ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water) and inflated properly with the balloon being symmetrical.With the syringe attached the balloon passively deflated within 1 min 37 seconds with no cuffing.No root cause could be found because the reported event was unconfirmed.The labeling is found to be adequate.A device history record review was not required as the investigation was unconfirmed.The investigation is concluded, and no additional action is required at this time.Correction: d.This report references a us equivalent device.The us udi equivalent for this product number is used.H11: sections 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 the customer contacted regarding a material safety report concerning foley silicone 3-way ch18 probes, reference (b)(4), batch nghq0771.The problem raised occurred on two occasions, a patient was catheterized with a catheter for bladder lavage.The catheter did not stay in place, and the balloon was found to be deflated and leaking after removal.This led to several catheterizations, which ended up being traumatic.On the other hand, the patient had no particular obstacle, and there were no handling problems as nurse who had already performed the procedure, doctor present, patient cooperative for (lot# nghq0771) and (lot# unk).A new incident occurred again with the same patient with a 3v ch20 probe, reference (b)(4) and did not have a sample for this probe (lot# nghp0228) and (lot# unk).Per follow up information received via ibc on 06jun2025, the patient had to be treated again, which became traumatic.The procedure was uncomfortable and causes a loss of time and stress.The event occurred first time was on (b)(6) 2025, and the second time was shortly afterwards on the same day.The two probes that became misaligned were discarded by the department.However, have several new probes from the same batch in possession, which could be send.There were 13 unused sample and used product not kept and cannot send them (pcn#(b)(6)) and stated that the probe became misaligned and had to be replaced, the date of event was 31may2025, the lot number was nghp0228.The sample in question has not been kept, but they had new probes from the same batch in stock, which they can also send.No photos were sent to them (pcn#(b)(6)).

• 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, GA 30014 ; 7707846100
• MDR Report Key: 22308636
• Report Number: 1018233-2025-04838
• Device Sequence Number: 20987901
• Product Code: EZL
• UDI-Device Identifier: 00801741034312
• UDI-Public: (01)00801741034312(11)220707(17)270706(10)NGGS1185
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K070558
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/28/2026

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: 73020L
• Device Lot Number: NGGS1185
• 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: 06/02/2025
• Supplement Date Received by Manufacturer: 01/26/2026; 01/28/2026
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 01/27/2026; 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2022
• 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