MAUDE Adverse Event Report: C.R. Bard, Inc. (BASD) -3006260740 Catheter Maintenance and Accessories, Footprint, Introducers (Stand Alone Kits)

Catalog Number	FMISHEATH1.4
Medical Device Problem Code	Misassembled (1398)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2026
Type of Reportable Event	Malfunction

• Brand Name: Catheter Maintenance and Accessories, Footprint, Introducers (Stand Alone Kits)
• Common Device Name: Catheter Maintenance and Accessories, Footprint, Introducers (Stand Alone Kits
• Manufacturer (Section D): C.R. Bard, Inc. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): Footprint Medical Inc.; 5823 sebastian place; san antonio TX 78249
• Manufacturer Contact: veronica lee ; 605 north 5600 west; salt lake city 84116 ; +1(801)595-0700
• MDR Report Key: 50567720
• Report Number: 3006260740-2026-06394
• Device Sequence Number: 10104944
• Product Code: DYB
• UDI-Device Identifier: 00858778006003
• UDI-Public: (01)00858778006003(10)260015
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K093026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2026

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: FMISHEATH1.4
• Device Lot Number: 260015
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/24/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2026
• Supplement Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 09/02/2026
• Supplement Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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