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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL SPINAL 25G WHITACRE NEEDLE; SPINAL ANESTHESIA KIT
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SMITHS MEDICAL SPINAL 25G WHITACRE NEEDLE; SPINAL ANESTHESIA KIT Back to Search Results
Model Number 49661C-25
Device Problem Break (1069)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 07/10/2017
Event Type  malfunction  
Event Description
Anesthesiologist was placing a single stick for intrathecal procedure.No csf return noted.Md felt a longer needle would likely be needed.Upon removal of whitacre 25g needle, it was noted that it had broken and a portion remained in the pt's tissue.Estimated that the remaining segment was about 1.25 inches.Surgeon notified.Neurosurgeon consulted.Pt notified.Decision made to proceed with scheduled procedure.Pt will be monitored.Needle fragment may need to be removed after pt recovers from current surgery.Note: single stick at l3-4.Stylette was straight and not deformed when removed.Device routed to risk management.Note: single stick at l3-4.Stylette was straight and not deformed when removed.Device routed to risk management and is being held.
 
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Brand Name
SPINAL 25G WHITACRE NEEDLE
Type of Device
SPINAL ANESTHESIA KIT
Manufacturer (Section D)
SMITHS MEDICAL
MDR Report Key6717307
MDR Text Key80266345
Report NumberMW5071003
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 Other Health Care Professional
Type of Report Initial
Report Date 07/13/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/13/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number49661C-25
Device Lot Number3439778
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age63 YR
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