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

Catalog Number 0070430

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/06/2021

Event Type  Injury  

Event Description

Pt post spine surgery.Ct scan of hip revealed drain fragment.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 dr. ; franklin lake NJ 07417 1880
• MDR Report Key: 12533274
• MDR Text Key: 273537945
• Report Number: 12533274
• Device Sequence Number: 1
• Product Code: GBP
• 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: 07/06/2021
• 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 Outcome(s): Required Intervention
• Patient Age: 29 YR
• Patient Weight: 50