MAUDE Adverse Event Report: BBRAUN MEDICAL, INC. PENCAN SPINAL NEEDLE TRAY; NEEDLE CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Model Number P25BK

Device Problem Output Problem (3005)

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

Event Date 03/06/2019

Event Type  malfunction  

Event Description

During an operating room case, a pencan spinal needle tray was used for spinal anesthesia.After placing the catheter and using the bupivacaine 0.75 percent with dextrose 8.25 percent, there was no spinal anesthetic effect.General anesthesia was necessary to continue the case.

• Brand Name: PENCAN SPINAL NEEDLE TRAY
• Type of Device: NEEDLE CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
• Manufacturer (Section D): BBRAUN MEDICAL, INC.; bethlehem PA 18018
• MDR Report Key: 8401660
• MDR Text Key: 138215355
• Report Number: MW5084726
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 03/06/2019

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 Model Number: P25BK
• Device Lot Number: 333851
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/07/2019
• Was Device Evaluated by Manufacturer?: No Information
• 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: 24 YR
• Patient Weight: 51