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

Catalog Number	319214A
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complete initial reporter's facility name is (b)(6) hospital.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: 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 during the pre-test, sterilized water could not be drawn from the foley catheter.
Additional Manufacturer Narrative
The reported event is confirmed-other.This is addressed by capa 12474540.Photo (1) shows one 3-way all silicone temp sensing foley catheter with sample port and syringe.Photo (2) shows catheter tip.Photo (3) shows valve cap with verified material number 119314 and lot number ngjw3468.Photo (4) shows packaging label with verified batch number mykr3301.Photo (5) shows a second 3-way all silicone temp sensing catheter with sample port and syringe.Photo (6) shows catheter tip and cuffing present.Photo (7) shows valve cap with verified material number 119314 and lot number ngkn0583.Functional testing was not possible solely on these photos.Receive 1 all silicone foley catheter with sample port and syringe.Visual inspection noted no obvious observations.This sample was tested for difficulty draining.Using the returned syringe, the catheter ballon was inflated with 10ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water).Inflated with no difficulty.Attempted to deflate balloon passively using returned syringe and only 1ml could be withdrawn within 5min.Using the in house luer lock syringe, deflated balloon passively and successfully in 01min with cuffing noted.Risk review, labeling review, and dhr review are not required as event has already been investigated per capa 12474540.Refer to capa for further details.Correction: d, e, f, h.Udi format updated with available product information per gudid.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 during the pretest, sterilized water could not be drawn from the foley catheter.Per notification from investigator on 20feb2026, it was reported that after deflation cuffing was present during sample evaluation on 03feb2026.

• Brand Name: LUBRI-SIL® I.C. COMPLETE CARE® TEMPERATURE-SENSING URINE METER FOLEY TRAY
• Common Device Name: SILICONE 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: 23357717
• Report Number: 1018233-2025-09445
• Device Sequence Number: 21050815
• Product Code: MJC
• UDI-Device Identifier: 00801741040153
• UDI-Public: (01)00801741040153(11)250618(17)270628(10)MYKR3301
• 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): 03/23/2026

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: MYKR3301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2025
• Supplement Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 10/22/2025
• Supplement Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2025
• 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