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	09/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a shortage of not having orange labels in foley kits to place on the bags.
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 there was a shortage of not having orange labels in foley kits to place on the bags.
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.
Additional Manufacturer Narrative
The reported event was inconclusive.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 specifications.Based on patient code 2645, the product does not appear to have been used.However, the product is intended to be used for treatment purpose but it is unknown whether the product had a relationship with the reported event.The device history record was reviewed and found a possible manufacturing issue that could have caused or contributed to the reported event.A labeling review was not performed because labeling could not have prevented the reported failure.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.H3 other text : the device was not returned.
Event or Problem Description
It was reported that there was a shortage of not having orange labels in foley kits to place on the bags.

• 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 15437804
• Report Number: 1018233-2022-07210
• Device Sequence Number: 20242834
• Product Code: MJC
• UDI-Device Identifier: 00801741073861
• UDI-Public: (01)00801741073861
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/19/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/31/2024
• Device Model Number: A319416AM
• Device Catalogue Number: A319416AM
• Device Lot Number: NGGP2149
• 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: 09/07/2022
• Supplement Date Received by Manufacturer: 09/20/2022; 01/20/2023
• Initial Report FDA Received Date: 09/16/2022
• Supplement Report FDA Received Date: 10/04/2022; 01/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2022
• 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