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

Catalog Number	919214A
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the pre-test, sterile water was injected into the foley catheter, but it was not possible to drain it.We also checked with the sales department and found that resistance was felt from the time the water was injected, and it was almost impossible to drain it.
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
Upon further review, bd has determined that this mdr was reported in error.The reported event is not attributed to a device malfunction.Submitting the investigation details as additional information.The reported event was confirmed- other.Received (4) photo samples.The photo sample was returned and could not be evaluated for the reported failure.Visual evaluation of the returned sample noted one opened (without original packaging), used silicone foley with syringe.Visual inspection of the sample noted that the balloon was partially inflated.Using the return syringe the catheter balloon was inflated with 10 ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water) and resistance felt while filling.With the syringe attached the catheter was only able to passively deflate 1ml of fluid within 5 minutes.Using the (in-house) syringe the catheter balloon was inflated with 10 ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water) and no issues observed.With the (in-house) syringe attached the catheter was able to passively deflate balloon within 5 minutes: 2 min 8 sec.The complaint is against the syringe.A review of the risk document was performed for this investigation.The reported event is addressed and the residual risk for this event is within the expected range.Product labeling was reviewed for this investigation.The labeling is found to be adequate.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.Complete initial reporter facility name: social welfare corporation onshi foundation saiseikai niigata kenou core hospital correction: d, e, h.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 during the pre-test, sterile water was injected into the foley catheter, but it was not possible to drain it.We also checked with the sales department and found that resistance was felt from the time the water was injected, and it was almost impossible to drain it.

• Brand Name: LUBRI-SIL® I.C. COMPLETE CARE® TEMPERATURE-SENSING URINE METER FOLEY TRAY
• Common Device Name: TEMPERATURE-SENSING URINE METER 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: 21559297
• Report Number: 1018233-2025-01562
• Device Sequence Number: 21136229
• Product Code: MJC
• UDI-Device Identifier: 00801741040122
• UDI-Public: (01)00801741040122(11)241105(17)270428(10)MYJW1900
• 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): 08/13/2025

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: 919214A
• Device Lot Number: MYJW1900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2025
• Supplement Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 03/10/2025
• Supplement Report FDA Received Date: 08/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2024
• 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