MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 LUBRI-SIL® I.C. COMPLETE CARE® TEMPERATURE-SENSING URINE METER FOLEY TRAY

Catalog Number	319214A
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that before use the foley catheter inflation valve was stiff and came off along with the syringe.Per follow up information received via rcc on (b)(6)2025, stated that it was unclear whether the event occurred was during water injection or withdrawal, but the syringe operation felt stiff.Per follow up information received via rcc on (b)(6)2025, stated that the foley catheter valve was disconnected.
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.
Additional Manufacturer Narrative
The reported event was unconfirmed.Received (4) photo samples.The photo sample was returned shows the overview of the foley catheter with syringe.The second and third photo shows the inflation cap/inflation port was disconnected and still attach in the syringe.The fourth photo shows the product packaging information.Visual evaluation of the returned sample noted one opened (without original packaging), used silicone foley with syringe 119314 and lot number ngjy4784.Visual inspection of the sample identified that the inflation cap/inflation port was disconnected.The inflation valve and cap were reinserted.Using a return syringe, the catheter balloon was inflated with 10 ml of methylene blue solution (prepared using 3 drops of 1percent aqueous methylene blue per 100 ml of distilled water.The balloon inflated without difficulty.Balloon concentricity was evaluated per tm0300903 using the formula: 1.6 / (1.6 plus 0.4)100, resulting in 80/20 concentricity.This result is consistent with the observed stiffness and the initial disconnection of the inflation cap/inflation port.Afterwards, with the return syringe attached, the balloon passively deflated the full 10 ml of solution within 41 seconds.A device history record review was not required as the investigation was unconfirmed.The investigation is concluded.Corrections made to tab d, h.Initial reporter complete facility name: hiroshima prefectural hospital organization hiroshima prefectural hospital 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 before use the foley catheter inflation valve was stiff and came off along with the syringe.Per follow up information received via rcc on 23sep2025, stated that it was unclear whether the event occurred was during water injection or withdrawal, but the syringe operation felt stiff.Per follow up information received via rcc on 24sep2025, stated that the foley catheter valve was disconnected.

• Brand Name: LUBRI-SIL® I.C. COMPLETE CARE® TEMPERATURE-SENSING URINE METER FOLEY TRAY
• Common Device Name: FOLEY TRAY
• 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: 23142547
• Report Number: 1018233-2025-08557
• Device Sequence Number: 9857395
• Product Code: MJC
• UDI-Device Identifier: 00801741040153
• UDI-Public: (01)00801741040153(11)25011617)300109(10)MYKR0241
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K070582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2026

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: 319214A
• Device Lot Number: MYKR0241
• 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: 09/19/2025
• Supplement Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 09/25/2025
• Supplement Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2025
• 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