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

Model Number 333320

Device Problem Bent (1059)

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

Event Date 02/07/2017

Event Type  malfunction  

Event Description

A pediatric patient was admitted to outpatient unit for a lumbar puncture and intrathecal chemotherapy.The physician was using a spinocan spinal needle, 22g x 3.5".The physician was unable to get the needle into the epidural space and the needle bent.He attempted with another needle, same gauge and again the needle bent.The physician complained the needles were too flimsy and they would not support the syringe for intrathecal chemotherapy if he were to get into the epidural space successfully.The physician then switched to a larger gauge 20g x 3.5." he does not prefer the larger gauge due to loss of extra cerebrospinal fluid which can cause negative side effects for the patient.This was successful.

• Brand Name: SPINOCAN
• Type of Device: NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd; allentown PA 18109
• MDR Report Key: 6371659
• MDR Text Key: 68773362
• Report Number: 6371659
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2017
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 333320
• Device Catalogue Number: 333320
• Device Lot Number: 0061517025
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/15/2017
• Device Age: 0 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 02/15/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 13 YR
• Patient Weight: 46