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

Catalog Number	947314
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2025
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.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.
Event or Problem Description
It was reported that during the activity, a new foley tray was used for the demonstration, but when it was opened for practical use, the lack of the syringe prefilled with the solution was detected, attached the data of said tray.Additional information received on 10feb2025, that it was during a training, the kit was opened in which the missing syringe was detected with sterile water.The prefilled syringe was not available, that's why it was not possible to know the detail of the material and batch since it was a component of the kit.The date of the event was 06feb2025.Per follow up information received on 18feb2025, they confirmed the involvement of the nursing staff who were involved when this event occurred, as it was during a training with new staff.
Event or Problem Description
It was reported that during the activity, a new foley tray was used for the demonstration, but when it was opened for practical use, the lack of the syringe prefilled with the solution was detected, attached the data of said tray.Additional information received on 10feb2025, that it was during a training, the kit was opened in which the missing syringe was detected with sterile water.The prefilled syringe was not available, that's why it was not possible to know the detail of the material and batch since it was a component of the kit.The date of the event was (b)(6) 2025.Per follow up information received on 18feb2025, they confirmed the involvement of the nursing staff who were involved when this event occurred, as it was during a training with new staff.
Additional Manufacturer Narrative
The reported event was inconclusive.The conditions of the sample did not allow further evaluation.Visual evaluation of the returned one-photo sample noted one opened (product packaging information insert), for the latex-free foley tray.Visual inspection of the one-photo sample noted that due to the condition of the photo sample the reported failure could not be evaluated therefore this investigation is considered inconclusive.No actions can be taken at this time since a root cause was not identified.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.The instructions for use were found adequate and states the following: bard ez-lok sampling port (indicated by the blue stem in the port) accepts luer lock or slip tip syringes 1.Occlude drainage tubing a minimum of 3 inches below the sampling port by kinking the tubing until urine is visible under the access site.2.Swab surface of bard ez-lok sampling port with antiseptic wipe.3.Using aseptic technique, position the syringe in the center of the sampling port.The syringe should be held perpendicular to the surface of the sampling port (at approximately 80 to 100 degree angle).Press the syringe firmly and twist gently to access the sampling port.4.Slowly aspirate urine sample into syringe and remove syringe from sample port.5.Unkink tubing and transfer urine specimen into specimen cup or follow hospital protocol.Discard syringe according to hospital protocol.6.Follow established hospital protocol for specimen labeling and transport to lab.Sterile unless package is opened or damaged, except for any individually packaged components within the tray which are not labeled as sterile.These components are not terminally sterilized.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Single use only.Do not re-sterilize.For urological use only.Warning: on catheter, do not use ointments or lubricants having a petrolatum base.They will damage the catheter and may cause balloon to burst.Warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practices and applicable local, state and federal laws and regulations.Visually inspect the product for any imperfections or surface deterioration prior to use.If package is opened or if any imperfection or surface deterioration is observed, do not use.Please consult product label and insert for any indications, contraindications, hazards, warnings, cautions and directions for use.Correction- d, e, h 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.

• Brand Name: BARD® FOLEY TRAY WITH LUBRI-SIL® ALL-SILICONE FOLEY CATHETER
• 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 30014 ; 7707846100
• MDR Report Key: 21459284
• Report Number: 1018233-2025-01242
• Device Sequence Number: 18189999
• Product Code: EZL
• UDI-Device Identifier: 00801741024924
• UDI-Public: (01)00801741024924(11)230130(17)250531(10)NGGZ1793
• Combination Product (Y/N): Y
• Initial Reporter Country: MX
• PMA/510(K) Number: K984084
• 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
• Report Date (Section B): 04/16/2025

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 Expiration Date: 05/31/2025
• Device Catalogue Number: 947314
• Device Lot Number: NGGZ1793
• 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: 02/06/2025
• Supplement Date Received by Manufacturer: 04/16/2025
• Initial Report FDA Received Date: 02/25/2025
• Supplement Report FDA Received Date: 04/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2023
• 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