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U.S. Department of Health and Human Services

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

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BRAUN PENCN SPINAL TRAY P25BK BUPIVICAINE 075% Back to Search Results
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.
 
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Brand NamePENCN SPINAL TRAY P25BK BUPIVICAINE 075%
Type of DevicePENCN SPINAL TRAY P25BK BUPIVICAINE 075%
Manufacturer (Section D)
BRAUN
bethlehem PA 18018
MDR Report Key5525714
MDR Text Key41224501
Report NumberMW5061246
Device Sequence Number1
Product Code CAZ
Reporter Country CodeUS
Number of Events Reported1
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 Received03/22/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number61452281
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 03/22/2016 Patient Sequence Number: 1
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