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

Model Number	A304716A
Medical Device Problem Code	Misassembled (1398)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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.The device was not returned.
Event or Problem Description
It was reported that the catheters were packaged incorrectly.
Event or Problem Description
It was reported that the catheters were packaged incorrectly.
Additional Manufacturer Narrative
The reported event was inconclusive as no sample was returned for evaluation.A potential failure mode could be ¿catheter adhered with tray components¿ with a potential root cause of "incorrect operation".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.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." 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.H3 other text : the device was not returned.
Additional Manufacturer Narrative
Upon further review, bd has determined that this is not a reportable event.The complainant initially reported that the catheters were packaged incorrectly, but additional details were not provided.Due to the limited information obtained, this event was reported in abundance of caution.A sample was not returned for evaluation so the event could not be confirmed.However, this is a known issue based on past reviews associated with this product, which is likely the result of a tray layout missassembly.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.H3 other text : the device was not returned.
Event or Problem Description
It was reported that the catheters were packaged incorrectly.

• Brand Name: SURESTEP¿ FOLEY TRAY SYSTEM BARDEX® IC COMPLETE CARE®
• Common Device Name: CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9684971
• Report Number: 1018233-2020-00883
• Device Sequence Number: 778372
• Product Code: MJC
• UDI-Device Identifier: 00801741104299
• UDI-Public: (01)00801741104299
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/07/2020

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: 09/30/2021
• Device Model Number: A304716A
• Device Catalogue Number: A304716A
• Device Lot Number: NGDS0980
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/15/2020
• Supplement Date Received by Manufacturer: 02/12/2020; 04/06/2020
• Initial Report FDA Received Date: 02/08/2020
• Supplement Report FDA Received Date: 02/14/2020; 04/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1