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

Model Number 1758SI16

Device Problems Deflation Problem (1149); Difficult to Remove (1528); Physical Resistance/Sticking (4012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/29/2020

Event Type  malfunction  

Event Description

When placing catheter there are no issues with placement or function, however when it is time to remove the catheter there is resistance when trying to deflate the balloon.When and if any fluid does return it is not the sterile water it is supposed to be, it is urine.In order for the catheter to be removed it has to be cut and removed that way.Equipment is foley catheter, size 16fr silicone lot #ngdu3876 on this particular event.

• Brand Name: BARDEX LUBRI-SIL I.C. 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: 10127818
• MDR Text Key: 194358176
• Report Number: 10127818
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741025228
• UDI-Public: 00801741025228
• 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: 06/04/2020,03/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1758SI16
• Device Catalogue Number: 1758SI16
• Device Lot Number: NGDU3876
• 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: 06/04/2020
• Event Location: Hospital
• Date Report to Manufacturer: 06/08/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 26645 DA
• Patient Weight: 61