MAUDE Adverse Event Report: BD BARD 7MM HUBLESS, SILICONE, FLAT DRAIN; 7 FRENCH BLAKE DRAIN

Catalog Number 0070430

Device Problem Fracture (1260)

Patient Problem Insufficient Information (4580)

Event Date 08/01/2021

Event Type  malfunction  

Event Description

Drain catheter broke into two pieces during removal.Retained fragment in back.Return to operating room to remove.

• Brand Name: BARD 7MM HUBLESS, SILICONE, FLAT DRAIN
• Type of Device: 7 FRENCH BLAKE DRAIN
• Manufacturer (Section D): BD ; 1 becton drive; franklin lake NJ 07417 1880
• MDR Report Key: 12533249
• MDR Text Key: 274541618
• Report Number: 12533249
• Device Sequence Number: 1
• Product Code: GBX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0070430
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/24/2021
• Distributor Facility Aware Date: 08/01/2021
• Event Location: Hospital
• 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: 62 YR
• Patient Weight: 89