• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. ESPOCAN SPINAL EPIDURAL ANESTHESIA KIT

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

B. BRAUN MEDICAL INC. ESPOCAN SPINAL EPIDURAL ANESTHESIA KIT Back to Search Results
Model Number 333192
Device Problem Component Missing (2306)
Patient Problem No Information (3190)
Event Date 10/25/2017
Event Type  malfunction  
Event Description
Espocan combined spinal and epidural anesthesia tray was missing the 25 ga. X 1-1/2 inch needle. The doctor was in the process of placing and epidural on a labor and delivery patient when he noticed the needle was not in the cse tray and thus had to open a new tray. Most recently it has been noted that subsequent trays have similar issues with either catheters (x2) missing or other spinal needles missing for a total of 4 trays missing components over past few months. Same brand, similar lots, similar reference numbers and expiration dates.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameESPOCAN
Type of DeviceSPINAL EPIDURAL ANESTHESIA KIT
Manufacturer (Section D)
B. BRAUN MEDICAL INC.
901 marcon blvd
allentown PA 18109
MDR Report Key6995801
MDR Text Key90877983
Report Number6995801
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 10/26/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/02/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/30/2018
Device Model Number333192
Device Catalogue Number333192
Device Lot Number0061560712
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/26/2017
Event Location Hospital
Date Report to Manufacturer10/26/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-