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

Model Number 04046964180590

Device Problems Material Integrity Problem (2978); Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 02/04/2019

Event Type  malfunction  

Event Description

Spinal bupivacaine did not last an appropriate duration.

• Brand Name: PENCAN SPINAL NEEDLE TRAY
• Type of Device: NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
• Manufacturer (Section D): B. BRAUN MEDICAL INC
• MDR Report Key: 8343318
• MDR Text Key: 136991330
• Report Number: MW5084089
• 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: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 02/04/2019

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 Expiration Date: 06/30/2020
• Device Model Number: 04046964180590
• Device Lot Number: 0061649507
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/14/2019
• 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: 64 YR