MAUDE Adverse Event Report: B. BRAUN MEDICAL, INC. PENCAN; SPINAL TRAY

Lot Number 0061579375

Device Problem Component Missing (2306)

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

Event Date 01/02/2018

Event Type  malfunction  

Event Description

Missing items in the spinal introducer kit.

• Brand Name: PENCAN
• Type of Device: SPINAL TRAY
• Manufacturer (Section D): B. BRAUN MEDICAL, INC.; 901 marcon blvd; allentown PA 18109
• MDR Report Key: 7697825
• MDR Text Key: 114338093
• Report Number: 7697825
• Device Sequence Number: 1
• Product Code: CAZ
• 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: 07/10/2018,01/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 0061579375
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/10/2018
• Date Report to Manufacturer: 07/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1