MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. PERIFIX; NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Model Number 332171

Device Problem Incomplete or Missing Packaging (2312)

Patient Problem Insufficient Information (4580)

Event Date 04/05/2023

Event Type  malfunction  

Event Description

Product is missing in package x 6.Package is sealed.

• Brand Name: PERIFIX
• Type of Device: NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 824 twelfth avenue; bethlehem PA 18018
• MDR Report Key: 16731954
• MDR Text Key: 313223674
• Report Number: 16731954
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 332171
• Device Catalogue Number: 332171
• Device Lot Number: 0061852423
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/05/2023
• Event Location: Hospital
• Date Report to Manufacturer: 04/13/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/13/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1