MAUDE Adverse Event Report: C. R. BARD, INC. BARDEX I.C. COMPLETE CARE; CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES

Catalog Number NGER3613

Device Problem Material Separation (1562)

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

Event Date 08/06/2020

Event Type  malfunction  

Event Description

During the administration of normal saline for a bladder irrigation via foley catheter, a "pop" sound was heard.Foley was removed and noted about 1 cm of the rubber was missing.Fda safety report id# (b)(4).

• Brand Name: BARDEX I.C. COMPLETE CARE
• Type of Device: CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES
• Manufacturer (Section D): C. R. BARD, INC.
• MDR Report Key: 10465038
• MDR Text Key: 204915142
• Report Number: MW5096311
• Device Sequence Number: 1
• Product Code: MJC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NGER3613
• Was Device Available for Evaluation?: No
• 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 Outcome(s): Other
• Patient Age: 33 YR
• Patient Weight: 29