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

Model Number A303416A

Device Problems Restricted Flow rate (1248); Improper Flow or Infusion (2954)

Patient Problems Pain (1994); No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bd represents all of 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.The device was not returned.

Event Description

It was reported that the catheters did not drain properly.The complainant reported that the patient complained of pain or ¿full feeling¿ and they saw there was not any urine output.The complainant noted that the patient would then be repositioned or the staff would have the patient get up to walk and the bag fills with urine.The complainant has reportedly talked to the staff about the vent on the bags and doing an accordion motion prior to inserting the foleys but the staff reportedly mentioned that the bags are sealed so tight that the vent doesn¿t seem to work like it should.No medical intervention was reported.

Event Description

It was reported that the catheters did not drain properly.The complainant reported that the patient complained of pain or ¿full feeling¿ and they saw there was not any urine output.The complainant noted that the patient would then be repositioned or the staff would have the patient get up to walk and the bag fills with urine.The complainant has reportedly talked to the staff about the vent on the bags and doing an accordion motion prior to inserting the foleys but the staff reportedly mentioned that the bags are sealed so tight that the vent doesn¿t seem to work like it should.No medical intervention was reported.

Manufacturer Narrative

The reported event could not be confirmed.No sample was returned for evaluation.A potential failure mode could be ¿does not provide a path for urine to flow from the sample port to the collection bag¿ with a potential root cause of ¿incorrect dimensions¿.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "bard® ez-lok® sampling port (indicated by the blue stem in the port) accepts luer lock or slip tip syringes.Occlude drainage tubing a minimum of 3 inches below the sampling port by kinking the tubing until urine is visible under the access site.Swab surface of bard® ez-lok® sampling port with antiseptic wipe.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.Slowly aspirate urine sample into syringe and remove syringe from sample port.Unkink tubing if necessary and transfer urine specimen into specimen cup or follow hospital protocol.Discard syringe according to hospital protocol.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 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.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".

• Brand Name: SURESTEP¿ FOLEY TRAY SYSTEM LUBRI-SIL® IC COMPLETE CARE®
• Type of Device: FOLEY TRAY - DRAIN BAG
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8757750
• MDR Text Key: 150258633
• Report Number: 1018233-2019-03574
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741073823
• UDI-Public: (01)00801741073823
• Combination Product (y/n): N
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 07/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: A303416A
• Device Catalogue Number: A303416A
• Device Lot Number: NGCZ3986
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1