MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. NERVE BLOCK TRAY

Model Number 570258

Device Problem Material Puncture/Hole (1504)

Patient Problem Insufficient Information (4580)

Event Date 03/04/2021

Event Type  malfunction  

Event Description

While trying to secure the needle in the needle block foam holder that comes with the tray, the needle easily pushed thru the bottom of the holder.There is potential for blood exposure from used needle.

• Brand Name: NERVE BLOCK TRAY
• Type of Device: NERVE BLOCK TRAY
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd; allentown PA 18109
• MDR Report Key: 11494739
• MDR Text Key: 240100514
• Report Number: 11494739
• Device Sequence Number: 1
• Product Code: OGJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/08/2021,03/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 570258
• Device Catalogue Number: 570258
• Device Lot Number: 0061719165
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/08/2021
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 03/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1