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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY WHITACRE; NEEDLE, CONDUCTION, ANESTHETIC
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BECTON DICKINSON AND COMPANY WHITACRE; NEEDLE, CONDUCTION, ANESTHETIC Back to Search Results
Model Number 409442
Device Problems Break (1069); Difficult to Remove (1528)
Patient Problem Foreign Body In Patient (2687)
Event Date 02/04/2019
Event Type  malfunction  
Event Description
Spinal needle broke in patient during anesthesia for another procedure.Two-inch fragment at least one inch deep to skin at l2-3, to the left of midline (parmedian approach used).Placement was difficult due to (b)(6) (midline and paramedian approaches attempted).After successful placement (as evident by anesthetic requirements at incision), spinal needle was withdrawn with introducer with mild difficulty, but only 2.5 inch came out.Discussed with husband and patient.Patient to have lumbar x-rays in the department to confirm location as portable film not adequate.Spinal surgery consult to be placed for possible removal.
 
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Brand Name
WHITACRE
Type of Device
NEEDLE, CONDUCTION, ANESTHETIC
Manufacturer (Section D)
BECTON DICKINSON AND COMPANY
1 becton drive
franklin lakes NJ 07417
MDR Report Key8330586
MDR Text Key135868384
Report Number8330586
Device Sequence Number1
Product Code BSP
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 02/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/12/2019
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number409442
Device Catalogue Number409442
Device Lot Number7314624
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/07/2019
Event Location Hospital
Date Report to Manufacturer02/12/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age28105 DA
Patient Weight107
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