MAUDE Adverse Event Report: LI ENTERPRISES LIBERTY LINE PRODUCTS; URINARY DRAINAGE BAG WITH ANTI RELUX DEVICE STERILE

Catalog Number UDB901S

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 10/06/2014

Event Type  malfunction  

Event Description

Liberty line products, urinary drainage bag kit, lot# 13gc0194.Product removed from package with blood on connection port, bio-matter on inside of connector.This was a supposedly sterile package from vendor.

• Brand Name: LIBERTY LINE PRODUCTS
• Type of Device: URINARY DRAINAGE BAG WITH ANTI RELUX DEVICE STERILE
• Manufacturer (Section D): LI ENTERPRISES; frederick MD
• MDR Report Key: 4189306
• MDR Text Key: 5161170
• Report Number: MW5038648
• Device Sequence Number: 1
• Product Code: FCN
• 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: 10/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UDB901S
• Device Lot Number: 13GC0194
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/07/2014
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 94 YR
• Patient Weight: 82