MAUDE Adverse Event Report: C. R. BARD, INC. BARDEX FOLEY CATHETER; CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES

Lot Number NGEW0878

Device Problems Obstruction of Flow (2423); No Flow (2991)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/04/2021

Event Type  malfunction  

Event Description

No inflow due to outflow obstructed - same lot number.Two foleys used on same patient.No harm to patient another used.Fda safety report id# (b)(4).

• Brand Name: BARDEX FOLEY CATHETER
• Type of Device: CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES
• Manufacturer (Section D): C. R. BARD, INC. ; covington GA 30014
• MDR Report Key: 12301546
• MDR Text Key: 266096183
• Report Number: MW5103121
• Device Sequence Number: 2
• Product Code: MJC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 08/06/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: NGEW0878
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 84 YR
• Patient Weight: 73