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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN MEDICAL, INC. PENCAN SPINAL TRAY

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B. BRAUN MEDICAL, INC. PENCAN SPINAL TRAY Back to Search Results
Lot Number 0061579375
Device Problem Component Missing (2306)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/02/2018
Event Type  malfunction  
Event Description
Missing items in the spinal introducer kit.
 
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Brand NamePENCAN
Type of DeviceSPINAL TRAY
Manufacturer (Section D)
B. BRAUN MEDICAL, INC.
901 marcon blvd
allentown PA 18109
MDR Report Key7697825
MDR Text Key114338093
Report Number7697825
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 07/10/2018,01/23/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/18/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number0061579375
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/10/2018
Event Location No Information
Date Report to Manufacturer07/18/2018
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? No
Type of Device Usage

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