MAUDE Adverse Event Report: C. R. BARD, INC. BARD FOLEY TRAY WITH LUBRI-SIL ALL-SILICONE FOLEY CATHETER; CATHETER, RETENTION TYPE, BALLOON

Model Number 908316

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504); Failure to Advance (2524); Device Dislodged or Dislocated (2923)

Patient Problem Insufficient Information (4580)

Event Date 09/07/2020

Event Type  malfunction  

Event Description

Rn attempted to place foley catheter in male patient.Upon placement and inflation of balloon, catheter fell out.Upon further investigation, it was noted there was a hole in the balloon because the sterile water leaked out.Rn attempted to place another foley catheter from a separate kit.Balloon was able to be inflated prior to insertion.However, after insertion and inflation, a "popping " sound was noted, and the second catheter fell out.Third attempt of foley placement was unsuccessful due to unable to pass prostate.Manufacturer response for foley catheter tray, bard lubri-sil 100% latex-free foley catheter tray (per site reporter).Equipment failure reported to bard medical customer services.Bard field assurance specialist ii, returned call.

• Brand Name: BARD FOLEY TRAY WITH LUBRI-SIL ALL-SILICONE FOLEY CATHETER
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10893988
• MDR Text Key: 217942396
• Report Number: 10893988
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/30/2020,10/26/2020

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: Health Professional
• Device Model Number: 908316
• Device Catalogue Number: 908316
• Device Lot Number: NGDZX181
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/30/2020
• Event Location: Hospital
• Date Report to Manufacturer: 11/24/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27740 DA
• Patient Weight: 103