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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HALYARD HEALTH, INC. KIMBERLY-CLARK TUOHY; NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
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HALYARD HEALTH, INC. KIMBERLY-CLARK TUOHY; NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER) Back to Search Results
Catalog Number 183A28
Device Problem Break (1069)
Patient Problems Headache (1880); Hemorrhage/Bleeding (1888)
Event Date 06/06/2016
Event Type  malfunction  
Event Description
During epidural spinal procedure for steroids, the spinal needle broke in two leaving half inside the patient.The needle was successfully removed by a spinal/orthopedic surgeon.The patient was given follow up instructions for headache and bleeding at the site and was instructed to go to the nearest emergency room for concerns.The patient presented at our emergency room with tension type headache and bleeding from the site.It was noted the steri-strip fell off.An x-ray was done in the ed where it was read negative for a foreign body.The patient was discharged with tension headache.
 
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Brand Name
KIMBERLY-CLARK TUOHY
Type of Device
NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
Manufacturer (Section D)
HALYARD HEALTH, INC.
5405 windward parkway
alpharetta GA 30004
MDR Report Key5757980
MDR Text Key48425107
Report Number5757980
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 User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 06/09/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator Physician
Device Expiration Date10/31/2020
Device Catalogue Number183A28
Device Lot NumberAA5285K06
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/09/2016
Event Location Hospital
Date Report to Manufacturer06/09/2016
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/29/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age63 YR
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