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

Model Number	A319516AM
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2022
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.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 or Problem Description
It was reported that there was no catheter in foley tray that connected to drainage tube.
Additional Manufacturer Narrative
The reported event was inconclusive, and it is unknown whether the device had met relevant specifications.The product was not used for patient treatment.It was unknown whether the product had caused the reported failure.Although a specific cause cannot be determined, based on the risk document a potential root cause for this event could be ¿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 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." h11: section a through f - the information provided by bard 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 bard.
Event or Problem Description
It was reported that there was no catheter in foley tray that connected to drainage tube.Per additional information received via sample form on (b)(6) 2022, customer stated that box opened and part was missing.

• Brand Name: SURESTEP¿ FOLEY TRAY SYSTEM LUBRI-SIL® IC COMPLETE CARE®
• Common Device Name: FOLEY TRAY SYSTEM
• 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: 15401366
• Report Number: 1018233-2022-07040
• Device Sequence Number: 6198364
• Product Code: MJC
• UDI-Device Identifier: 00801741073892
• UDI-Public: (01)00801741073892
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K070582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2023

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: 02/29/2024
• Device Model Number: A319516AM
• Device Catalogue Number: A319516AM
• Device Lot Number: NGFZ1360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/29/2022
• Supplement Date Received by Manufacturer: 02/17/2023
• Initial Report FDA Received Date: 09/12/2022
• Supplement Report FDA Received Date: 02/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2021
• 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