MAUDE Adverse Event Report: B.BRAUN PENCAN SPINAL ANESTHESIA TRAY; SPINAL TRAY

Model Number SSK

Device Problem Component Missing (2306)

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

Event Date 09/14/2017

Event Type  malfunction  

Event Description

Introducer was missing from spinal kit.Upon opening the pencan spinal anesthesia tray, there were no 20ga x 1.375in (35mm) introducer needle found.Procedure was aborted using spinal tray and another method of spinal anesthesia was used.Date of use: (b)(6) 2017.Diagnosis or reason for use: hip replacement.

• Brand Name: PENCAN SPINAL ANESTHESIA TRAY
• Type of Device: SPINAL TRAY
• Manufacturer (Section D): B.BRAUN
• MDR Report Key: 6885844
• MDR Text Key: 87301386
• Report Number: MW5072291
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Model Number: SSK
• Device Catalogue Number: 560327
• Device Lot Number: 0061558566
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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: 92 YR