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

Model Number 942216

Device Problems Fluid/Blood Leak (1250); Device Fell (4014)

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

Event Date 08/18/2022

Event Type  malfunction  

Event Description

Patient had foley catheter placed in the ed.The catheter fell out and had to be replaced by the rn.The rn tested the balloon of the catheter that had "fallen out" and observed that the injected fluid immediately leaked out.

• Brand Name: BARD URINE METER 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: 15310086
• MDR Text Key: 298774394
• Report Number: 15310086
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741024979
• UDI-Public: (01)00801741024979(17)240331(10)NGGQ2730
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/25/2022

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 Model Number: 942216
• Device Catalogue Number: 942216
• Device Lot Number: NGGQ2730
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/25/2022
• Event Location: Hospital
• Date Report to Manufacturer: 08/29/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/29/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25185 DA
• Patient Sex: Male
• Patient Weight: 68 KG
• Patient Race: White