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

Catalog Number	A303416A
Medical Device Problem Codes	Device Contamination with Chemical or Other Material (2944); Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2024
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.Udi format updated with available product information per gudid.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 the customer had 3 different issues with the foley tray all with same lot#.The first issue was there was a small bug (gnat) inside the packaging, second issue stated there was an orange thread inside the packaging and the last issue stated there was a hole on inside wrapper.Per follow up via email on 02jan2025, it was reported that pk7645844 was the only number outside the packaging to identify the product.The exact date of occurrence was not noted.The defect was noticed prior to use.
Additional Manufacturer Narrative
The reported event was confirmed cause unknown.No actions can be taken at this time since a root cause was not identified.Visual evaluation of the returned two-photo sample noted one opened (with original packaging), surestep foley trays.Visual inspection of the two-photo sample noted that a gnat was tape to the product packaging.This does not meet specification which states the product/assembly must be free of visible, lose or etched foreign matter, solvent spills, hair, etc.The device history record review could not be performed without a lot number.The instructions for use were found adequate and state the following: intended for use in the drainage and/or collection and/or measurement of urine.Generally, drainage is accomplished by inserting the catheter through the urethra and into the bladder.However, drainage is sometimes accomplished by suprapubic or other placement of the catheter, such as a nephrostomy tract.¿warning: do not use if allergic to iodine.For urological use only.Warning: on catheter, do not use ointments or lubricants having a petrolatum base.They will damage silicone and may cause balloon to burst patient has acute urinary retention or bladder outlet obstruction need for accurate urine output measurements in critically ill patients use for selected surgical procedures to assist in healing of open sacral or perineal wounds patient requires prolonged immobilization to improve comfort for end-of-life care.Udi format updated with available product information per gudid.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 customer had 3 different issues with the foley tray all with same lot#.The first issue stated there was a small bug (gnat) inside the packaging.Second issue stated there was an orange thread inside the packaging and the last issue stated there was a hole on inside wrapper.Customer did not have trays but had parts of trays with the bug and stain.Per follow up via email on 02jan2025, it was reported that pk7645844 was the only number outside the packaging to identify the product.The exact date of occurrence was not noted.The defect was noticed prior to use.

• Brand Name: SURESTEP¿ FOLEY TRAY SYSTEM LUBRI-SIL® IC COMPLETE CARE®
• Common Device Name: FOLEY TRAY
• Manufacturer (Section D): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 21078794
• Report Number: 1018233-2024-08541
• Device Sequence Number: 12842727
• Product Code: EZL
• UDI-Device Identifier: 00801741073823
• UDI-Public: (01)00801741073823
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K040504
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2025

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 Catalogue Number: A303416A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2024
• Supplement Date Received by Manufacturer: 03/13/2025
• Initial Report FDA Received Date: 01/06/2025
• Supplement Report FDA Received Date: 03/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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