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

Model Number A304716A

Device Problems Misassembled (1398); Packaging Problem (3007)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.

Event Description

It was reported that the catheters in the kits were misplaced in the package.When the customer opened one of a different lot, they noticed there was not an issue and it was packaged appropriately.

Event Description

It was reported that the catheters in the kits were misplaced.

Manufacturer Narrative

The reported event was confirmed.The device did not meet specifications.The product was intended to be used for treatment purposes.The product was influenced by the reported failure.Visual evaluation of the returned sample noted 2 opened (with original packaging) and 4 unopened (inside original packaging), surestep foley trays.Visual inspection of the opened samples noted that both had catheters misplaced within the tray.This caused the blue sleeves to become partially removed from the catheters.The unopened samples were removed from their packaging, and 2 had catheters misplaced within the tray in the same manner.This is out of specification per inspection procedure, which states, "product must conform to drawing." drawing (b)(4), revision 4 illustrates the correct layout of the catheter in the tray.It also illustrates the sleeve completely surrounding the catheter.Although the reported event was confirmed, the root cause could not be determined.A potential root cause for this failure could be, ¿inadequate retention." 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 (fig.1a) or slip tip syringes (fig.1b).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.(fig.2) 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.(fig.3) 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.Bard, ez-lok and statlock are trademarks and/or registered trademarks of c.R.Bard, inc.©2017 c.R.Bard, inc.All rights reserved.Pk7646070 03/2017 www.Bardmedical.Com manufacturer: bard medical division c.R.Bard, inc.8195 industrial blvd.Covington, ga 30014 usa 1.800.526.4455 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.Ez-lok® sampling port fig.3 fig.2 fig.1a fig.1b sterilized using ethylene oxide.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 released" h11:section a through f - 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.

Event Description

It was reported that the catheters in the kits were misplaced.

Manufacturer Narrative

Upon further review, bd has determined that this is not a reportable event based on the results of the investigation findings.The complainant initially reported that the catheters were misplaced in the package, but additional details were not provided.Due to the limited information obtained, this event was reported in abundance of caution.The evaluation of the sample received confirmed the reported issue which indicated that the blue sleeve was partially removed from the catheter.Although the reported event was confirmed, there is no significant risk of patient harm or long-term health consequences associated with this issue.Additionally, a user would likely open the package and identify the issue prior to use leading to replacement of the device.H11:section a through f - 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.

• Brand Name: SURESTEP¿ FOLEY TRAY SYSTEM BARDEX® IC COMPLETE CARE®
• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9629345
• MDR Text Key: 181169494
• Report Number: 1018233-2020-00507
• Device Sequence Number: 1
• Product Code: MJC
• UDI-Device Identifier: 00801741104299
• UDI-Public: (01)00801741104299
• Combination Product (y/n): N
• PMA/PMN Number: K040658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 04/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/20/2021
• Device Model Number: A304716A
• Device Catalogue Number: A304716A
• Device Lot Number: NGDX4745
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2020
• Date Manufacturer Received: 04/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1