MAUDE Adverse Event Report: BRAUN PENCN SPINAL TRAY P25BK BUPIVICAINE 075%

Lot Number 61452281

Device Problems Unexpected Therapeutic Results (1631); Device Operates Differently Than Expected (2913); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 03/22/2016

Event Type  malfunction  

Event Description

Three pencan spinal trays were used in the past week made by braun and there was failure to achieve a satisfactory spinal block in pts receiving c-section and they required anesthesia.Lot #61452281, 61468725-6148723.It was thought there may have been a potency issue with the bupivicaine 0.75% and possibly the temperature in the storage area was up to 78'f for a day or so.

• Brand Name: PENCN SPINAL TRAY P25BK BUPIVICAINE 075%
• Type of Device: PENCN SPINAL TRAY P25BK BUPIVICAINE 075%
• Manufacturer (Section D): BRAUN; bethlehem PA 18018
• MDR Report Key: 5525714
• MDR Text Key: 41224501
• Report Number: MW5061246
• Device Sequence Number: 1
• Product Code: CAZ
• 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: 03/22/2016
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 61452281
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other