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

Model Number 303116A

Device Problem Deflation Problem (1149)

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

Event Date 11/11/2016

Event Type  malfunction  

Event Description

Foley catheter inserted during spinal surgery would not deflate at the end of the case.Patient to post-anesthesia care unit (pacu) then the foley catheter was able to come out but the balloon stayed slightly inflated.

• Brand Name: LUBRI-SIL
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): C. R. BARD, INC.; 1211 mary magnan blvd.; madison GA 30650
• MDR Report Key: 6208654
• MDR Text Key: 63400886
• Report Number: 6208654
• 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: 11/22/2016

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 Expiration Date: 09/30/2019
• Device Model Number: 303116A
• Device Catalogue Number: 303116A
• Device Lot Number: NGAS1438
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/22/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 11/22/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 37 YR