MAUDE Adverse Event Report: C. R. BARD, INC. FOLEY CATHETER; CATHETER, UROLOGICAL

Device Problems Leak/Splash (1354); Tear, Rip or Hole in Device Packaging (2385)

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

Event Date 04/04/2022

Event Type  malfunction  

Event Description

Rn noted leaking when she had emptied the bag and feels it is coming from the bottom portion of the bag this time, instead of near the urimeter where we have previously seen trends with this product developing holes.Leaking (non-intact) foley bags p[lace patients at risk for cauti, and this is an immunosuppressed post-heart transplant patient, which places him at higher risk for infectious complications.

• Brand Name: FOLEY CATHETER
• Type of Device: CATHETER, UROLOGICAL
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 15258109
• MDR Text Key: 298216391
• Report Number: 15258109
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/14/2022

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
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/14/2022
• Event Location: Hospital
• Date Report to Manufacturer: 08/19/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/19/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 23725 DA
• Patient Sex: Male
• Patient Weight: 83 KG
• Patient Race: White