MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 SURESTEP¿ FOLEY TRAY SYSTEM BARDEX® IC COMPLETE CARE®

Catalog Number	A303316A
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2024
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.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 there was a brown material in the sterile flush that is included in the foley tray.
Additional Manufacturer Narrative
The reported event was confirmed with cause unknown.Visual evaluation of the returned sample photo noticed the sterile water syringe with evident foreign material.This is out of specification which states, loose foreign matter.Although a specific cause cannot be determined, based on the risk document a potential root cause for this event could be ¿defective / contaminated components from supplier¿.The dhr review did not show any problems or conditions would have contributed to the reported event.The instructions for use were found adequate and states the following: "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 resterilize.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.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.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 if necessary 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.Directions for use: proper techniques for urinary catheter insertion.Perform hand hygiene immediately before and after insertion.Insert urinary catheters using aseptic technique and sterile equipment.Use the smallest foley catheter possible, consistent with good drainage.Document the indications for catheter insertion, date and time of catheter insertion, individual who inserted catheter, and date and time of catheter removal in patient record.Proper techniques for urinary catheter maintenance.Secure the foley catheter, use the statlock® foley stabilization device if provided.Maintain a closed drainage system by utilizing pre-connected, sealed catheter-tubing junctions.Maintain unobstructed urine flow and keep the catheter and collection tube free from kinking.Keep the collection bag below the level of the bladder or hips at all times.Empty the collection bag regularly (e.G., prior to transport) using a separate, clean collection container for each patient.Routine hygiene (e.G., cleansing of the meatal surface during daily bathing or showering) is appropriate.Leave foley catheter in place only as long as needed." 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.H3 other text : the actual/suspected device was inspected.
Event or Problem Description
It was reported that there was a brown material in the sterile flush that is included in the foley tray.Per customer follow up received on 18jan2024, seh experienced a quality issue with a bard bd foley kit.This occurred on 7c at seh edg.The syringe was not opened.The black rubber stopper was never removed.There was a brown foreign object seen just above the yellow arrow in the photo attached.Lot number nghw1475.

• Brand Name: SURESTEP¿ FOLEY TRAY SYSTEM BARDEX® IC COMPLETE CARE®
• Common Device Name: FOLEY TRAY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 18695042
• Report Number: 1018233-2024-00682
• Device Sequence Number: 20961983
• Product Code: MJC
• UDI-Device Identifier: 00801741073793
• UDI-Public: (01)00801741073793
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K040658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2024

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: 01/31/2026
• Device Catalogue Number: A303316A
• Device Lot Number: NGHW1475
• 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: 01/24/2024
• Supplement Date Received by Manufacturer: 04/05/2024
• Initial Report FDA Received Date: 02/13/2024
• Supplement Report FDA Received Date: 04/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/13/2023
• 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