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

Catalog Number 1758SI16

Device Problems Fluid/Blood Leak (1250); Hole In Material (1293)

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

Event Date 06/21/2017

Event Type  malfunction  

Event Description

Patient informed rn that she was wet despite the fact she had a foley catheter in place.Rn assessed and indeed, the bed was saturated with urine.Upon further investigation, a pin hole was noted near the "y" site near the ports where the catheter bag connects and the balloon is inflated.Urine was bubbling from the site.

• Brand Name: BARDEX LUBRI-SI
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): C.R. BARD, INC.; 1211 mary magnan blvd.; madison GA 30650
• MDR Report Key: 6696866
• MDR Text Key: 79454034
• Report Number: 6696866
• 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: 06/22/2017

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: NGAR3579
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/22/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 06/22/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO
• Patient Age: 69 YR