MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG PENCAN SPINAL NEEDLE TRAY; NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Lot Number 0061651360

Device Problems Difficult to Advance (2920); No Flow (2991)

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

Event Date 04/22/2019

Event Type  malfunction  

Event Description

B braun pencan spinal needle tray.Reported issues with the spinal kits.Reported issues with the inner lumens of the 25 gauge spinal needle and the 20 gauge spinal introducer.They found it difficult to advance the 25 gauge spinal needle through the 20 gauge introducer.They also found that the cerebrospinal fluid (csf) was not flowing as expected through the 25 gauge spinal needle.

• Brand Name: PENCAN SPINAL NEEDLE TRAY
• Type of Device: NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; 901 marcon blvd.; allentown PA 18109
• MDR Report Key: 8607287
• MDR Text Key: 144955089
• Report Number: 8607287
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/09/2019,04/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 0061651360
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/09/2019
• Date Report to Manufacturer: 05/14/2019
• Type of Device Usage: N
• Patient Sequence Number: 1