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

Model Number	A319416AM
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2022
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.
Event or Problem Description
It was reported that representative got a report that the foley trays did not contain betadine or lubricant syringe.Representative was trying to determine if there was something wrong with the kit, or if they need to do some education on the substitutes.Representative was given response that the label for each tray was attached which provides a detailed list of items included and was also told that a119216m contains lubrisil all silicone temperature sensing 16fr foley, statlock, control-fit outlet device drainage tube collection bag (2500 ml), 3 foam swabs, povidone iodine packet, peri-care kit (soap towelettes & hand sanitizer), a319416am contains bardex infection control 16fr temperature sensing foley, statlock, anti-microbial control-fit outlet device 350ml urine meter bacteriostatic collection bag (2500ml), 3 foam swabs, povidone iodine packet, peri-care kit (soap towelettes & hand sanitizer).
Event or Problem Description
It was reported that representative got a report that the foley trays did not contain betadine or lubricant syringe.Representative was trying to determine if there was something wrong with the kit, or if they need to do some education on the substitutes.Representative was given response that the label for each tray was attached which provides a detailed list of items included and was also told that a119216m contains lubrisil all silicone temperature sensing 16fr foley, statlock, control-fit outlet device drainage tube collection bag (2500 ml), 3 foam swabs, povidone iodine packet, peri-care kit (soap towelettes & hand sanitizer), a319416am contains bardex infection control 16fr temperature sensing foley, statlock, anti-microbial control-fit outlet device 350ml urine meter bacteriostatic collection bag (2500ml), 3 foam swabs, povidone iodine packet, peri-care kit (soap towelettes & hand sanitizer).
Additional Manufacturer Narrative
Upon further review, bd has determined that this mdr was reported in error as it was found to be a duplicate of an event previously reported.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.

• Brand Name: SURESTEP¿ FOLEY TRAY SYSTEM BARDEX® I.C. COMPLETE CARE FOLEY CATHETER
• Common Device Name: COMPLETE CARE FOLEY CATHETER
• 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 15445934
• Report Number: 1018233-2022-07234
• Device Sequence Number: 11944488
• Product Code: MJC
• UDI-Device Identifier: 00801741073861
• UDI-Public: (01)00801741073861
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2022

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 Model Number: A319416AM
• Device Catalogue Number: A319416AM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/01/2022
• Supplement Date Received by Manufacturer: 09/21/2022
• Initial Report FDA Received Date: 09/19/2022
• Supplement Report FDA Received Date: 09/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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