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

Catalog Number	900114A
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2025
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 during pre-test the foley catheter water drainage was slow.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Correction: d.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 pre-test the foley catheter water drainage was slow.
Event or Problem Description
It was reported that during pre-test the foley catheter water drainage was slow.
Additional Manufacturer Narrative
The complete initial reporter facility name is (b)(6).Upon further review, bd has determined that this mdr was reported in error.There is no allegation against a bd product but on a component in the tray.This report is being submitted as additional information.The reported event is 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 temp sensing foley catheter with syringe.Visual inspection of the sample noted no physical defects present.Using the return syringe attempted to the inflated catheter balloon with 10 ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water) and inflated properly.With the syringe attached the balloon did not deflate passively in under 5 min.Using the (in-house) syringe the balloon inflated ok and deflated passively with no issues deflated in under 5 min: 1min and 41sec.The complaint is against the syringe.The device history record review could not be performed without a lot number of the tray/syringe.Based on the results of the investigation, no additional actions are required at this time.The labeling is found to be adequate to fulfill s03fa211 revision 26.Corrections: d, 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.

• Brand Name: LUBRI-SIL® I.C. COMPLETE CARE® ALL-SILICONE FOLEY CATHETER 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: 21730528
• Report Number: 1018233-2025-02133
• Device Sequence Number: 4108716
• Product Code: MJC
• UDI-Device Identifier: 00801741032929
• UDI-Public: (01)00801741032929
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K984136
• 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,Followup
• Report Date (Section B): 08/06/2025

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: 900114A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2025
• Supplement Date Received by Manufacturer: 08/01/2025; 08/06/2025
• Initial Report FDA Received Date: 03/31/2025
• Supplement Report FDA Received Date: 08/06/2025; 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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