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

Catalog Number 903216

Device Problems Defective Component (2292); Component Missing (2306)

Patient Problems Hemorrhage/Bleeding (1888); Discomfort (2330)

Event Date 03/29/2018

Event Type  malfunction  

Event Description

When foley catheter was removed due to lack of drainage, tip of catheter was missing.Pt stated that when catheter was placed, "it felt rough and scratchy".Prior to replacing catheter, small amount of bleeding was noted around the urethra.Based on description of how catheter felt when placed and bleeding around urethra, we think the catheter was defective and tip was missing.Bard lubri-sil 100% latex-free 350ml urine meter foley catheter tray.

• Brand Name: BARD LUBRI-SIL URINE METER FOLEY CATHETER TRAY
• Type of Device: CATHETER, RETENTION
• Manufacturer (Section D): C. R. BARD, INC.; covington GA 30014
• MDR Report Key: 7395326
• MDR Text Key: 104452470
• Report Number: MW5076284
• 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: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: 903216
• Device Lot Number: NGBU1350
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 22 YR
• Patient Weight: 90