MAUDE Adverse Event Report: NULL PORTEX SPINAL NEEDLE.

Device Problem Material Fragmentation (1261)

Patient Problem No Information (3190)

Event Date 01/14/2020

Event Type  malfunction  

Event Description

Information received a smiths medical portex epidural during a procedure a spinal placement was placed mid-line at l2-3 and on the first attempt csf was unable to be obtained.Upon withdrawal of introducer and needle the spinal needle was noted to be broken.No additional information.Unknown the name of the facility reporting and if injury occurred.

• Brand Name: PORTEX SPINAL NEEDLE.
• Manufacturer (Section G): NULL
• MDR Report Key: 10270478
• MDR Text Key: 199476720
• Report Number: 3012307300-2020-07257
• Device Sequence Number: 1
• Product Code: MIA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/14/2020

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: No Information
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/17/2020
• Initial Date FDA Received: 07/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1