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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B BRAUN MEDICAL INC. SPINAL NEEDLE; NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
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B BRAUN MEDICAL INC. SPINAL NEEDLE; NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER) Back to Search Results
Model Number 04046964180590
Device Problems Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/06/2020
Event Type  Injury  
Event Description
Pt was scheduled for surgery spinal anesthetic with general anesthesia backup.During the removal of the needle, the tip of the needle was noted to be missing.X-ray confirmed 1/3 of the needle was lodged in the subcutaneous tissue.Md was notified of event and needle was remove under geta.Physician was able to locate the needle in the deep fascia and verified it was bent.Wound irrigated and needle sent to pathology.Per pathology report (b)(6) 2020, foreign body needle removal-container contains a bent needle measuring 4.5cm in length.Mfr's name: b.Braun medical inc., with a gtin# (b)(4) and lot# 00616990252, all are consistent with spinal needles.Fda safety report id# (b)(4).
 
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Brand Name
SPINAL NEEDLE
Type of Device
NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
Manufacturer (Section D)
B BRAUN MEDICAL INC.
MDR Report Key9580876
MDR Text Key175085711
Report NumberMW5092165
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 Risk Manager
Type of Report Initial
Report Date 01/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/31/2020
Device Model Number04046964180590
Device Lot Number00616990252
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age67 YR
Patient Weight99
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