MAUDE Adverse Event Report: C.R. BARD, INC. LUBRI-SIL; CATHETER, RETENTION TYPE, BALLOON

Catalog Number 1758SI16

Device Problems Difficult to Remove (1528); Failure to Advance (2524); Physical Resistance (2578)

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

Event Date 12/12/2016

Event Type  malfunction  

Event Description

The foley was ordered to be discharged and discontinued.The foley balloon (passively)deflated with a 10cc syringe.Attempted to remove the foley from patient and met resistance at length of foley where balloon is attached.A new 10cc syringe was attached to attempt to deflate balloon further.No fluid was returned in syringe.We attempted to re-advance the foley however were unable due to resistance.Smaller syringes (3 and 5cc) attached to attempt to further deflate balloon without success.A second rn attempted to remove catheter without success.Foley finally removed after attempting to use more force to withdraw past meatus.When the foley was removed the area where the balloon sits on the catheter was noted to be slightly enlarged and possibly caused the resistance upon removal.

• Brand Name: LUBRI-SIL
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): C.R. BARD, INC.; 8195 industrial blvd.; covington GA 30014
• MDR Report Key: 6233178
• MDR Text Key: 64176200
• Report Number: 6233178
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/14/2016

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: No Information
• Device Catalogue Number: 1758SI16
• Other Device ID Number: 1758SI16
• 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: 12/14/2016
• Event Location: Hospital
• Date Report to Manufacturer: 12/14/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/09/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 63 YR