MAUDE Adverse Event Report: BRAUN PENCAN SPINAL TRAY; SPINAL NEEDLE

Catalog Number 333851

Device Problem Bent (1059)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/15/2016

Event Type  Injury  

Event Description

Anesthesia put needle into spinal column through introducer and the needle bent, approx 2 cms.When the needle was removed from the sheath it appeared as though the sheath cut of the bent portion of the needle and the 2 cm portion of the needle was left in the pt.Imaging was obtained, pt was taken to the operating room, broken needle successfully removed.Diagnosis or reason for use: spinal block.

• Brand Name: PENCAN SPINAL TRAY
• Type of Device: SPINAL NEEDLE
• Manufacturer (Section D): BRAUN; bethlehem PA 18031
• MDR Report Key: 5888363
• MDR Text Key: 52624534
• Report Number: MW5064185
• Device Sequence Number: 1
• Product Code: BSP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 333851
• Device Lot Number: 61493108
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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: 50 YR
• Patient Weight: 109