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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. PENCAN SPINAL NEEDLE TRAY; NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

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B. BRAUN MEDICAL INC. PENCAN SPINAL NEEDLE TRAY; NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER) Back to Search Results
Model Number 333868
Device Problem Defective Component (2292)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
B.Braun medical inc., pencan spinal needle trays with same lot numbers noted to be ineffective.Three attempted and failed spinal anesthetics noted by anesthesia physicians.Fda safety report id# (b)(4).
 
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Brand Name
PENCAN SPINAL NEEDLE TRAY
Type of Device
NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
Manufacturer (Section D)
B. BRAUN MEDICAL INC.
bethlehem PA 18018
MDR Report Key8649823
MDR Text Key146481613
Report NumberMW5086938
Device Sequence Number1
Product Code BSP
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 05/23/2019
3 Devices were Involved in the Event: 1   2   3  
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date07/01/2020
Device Model Number333868
Device Catalogue NumberP24BK
Device Lot Number0061665983
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/28/2019
Type of Device Usage N
Patient Sequence Number1
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