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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B.BRAUN MEDICAL, INC. ESPOCAN 20G CLOSED TIP COMBINED SPINAL EPIDURAL ANESTHESIA TRAY

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B.BRAUN MEDICAL, INC. ESPOCAN 20G CLOSED TIP COMBINED SPINAL EPIDURAL ANESTHESIA TRAY Back to Search Results
Model Number 0061615216
Device Problems Break (1069); Detachment of Device or Device Component (2907)
Patient Problem No Code Available (3191)
Event Date 09/10/2018
Event Type  malfunction  
Event Description
Patient arrived to labor and delivery for c-section. Epidural catheter tip broke off during placement. Dates of use: (b)(6) 2018. The product is not compounded, not otc product; single use.
 
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Brand NameESPOCAN 20G CLOSED TIP
Type of DeviceCOMBINED SPINAL EPIDURAL ANESTHESIA TRAY
Manufacturer (Section D)
B.BRAUN MEDICAL, INC.
MDR Report Key7926215
MDR Text Key122624812
Report NumberMW5080268
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 Voluntary
Reporter Occupation
Type of Report Initial
Report Date 09/17/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/01/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2019
Device Model Number0061615216
Device Catalogue Number333192
Device Lot Number0061615216
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?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage

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