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 the foley tray did not contain betadine or the syringe of lubricant.The customer asked if both of these kits included those items, and they were just trying to determine if there was something wrong with the kit or if they needed to did some education on their subs.The label for each tray was attached, which provided a detailed list of items included that a119216m contained lubrisil all silicone temp 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) and a319416am contained bardex ic 16fr temp 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 the foley tray did not contain betadine or the syringe of lubricant.The customer asked if both of these kits included those items, and they were just trying to determine if there was something wrong with the kit or if they needed to did some education on their subs.The label for each tray was attached, which provided a detailed list of items included that a119216m contained lubrisil all silicone temp 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) and a319416am contained bardex ic 16fr temp 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
The reported event was inconclusive because no sample was returned for evaluation.A potential root cause for this failure could be due to "incorrect operation".It was unknown whether the device had met relevant specifications.The product was not used on the patient.It was unknown whether the product had caused the reported failure.The lot number was unknown; therefore, the device history record could not be reviewed.A labeling review is not required because labeling could not have prevented the reported issue.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® I.C. COMPLETE CARE FOLEY CATHETER
• Common Device Name: FOLEY TRAY
• 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: 15446047
• Report Number: 1018233-2022-07235
• Device Sequence Number: 20715408
• Product Code: MJC
• UDI-Device Identifier: 00801741073861
• UDI-Public: (01)00801741073861
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,Consumer,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2022

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: 12/30/2022
• Initial Report FDA Received Date: 09/19/2022
• Supplement Report FDA Received Date: 01/03/2023
• 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