MAUDE Adverse Event Report: B. BRAUN BETLEHEM B BRAUN - SPINOCAN SPINAL NEEDLE 25 GA. X 4-3/4 IN

Model Number SPINOCAN

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/22/2016

Event Type  malfunction  

Event Description

Upon removal of the spinocan spinal needle 25 ga.X 4-3/4 in (12 cm).Approximately 7 cm of needle was not present.The family and surgeon were notified immediately.Fluoroscopy was used intra-operatively to confirm the retained product.The surgery was uneventful.A spine surgeon was consulted and the family/patient chose to leave the needle in for now.

• Brand Name: B BRAUN - SPINOCAN SPINAL NEEDLE 25 GA. X 4-3/4 IN
• Type of Device: SPINAL NEEDLE
• Manufacturer (Section D): B. BRAUN BETLEHEM; PA 18018 3524
• MDR Report Key: 5476491
• MDR Text Key: 39670094
• Report Number: MW5060664
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 02/29/2016

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 Operator: Health Professional
• Device Expiration Date: 12/01/2019
• Device Model Number: SPINOCAN
• Device Lot Number: 61412256
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/29/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 117