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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX NO EPINEPHRINE, SPINAL KIT; NEEDLE SPINAL, SHORT TERM
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SMITHS MEDICAL ASD, INC. PORTEX NO EPINEPHRINE, SPINAL KIT; NEEDLE SPINAL, SHORT TERM Back to Search Results
Model Number NEPI-NLD-15583C-21
Device Problem Output Problem (3005)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/24/2019
Event Type  malfunction  
Event Description
Smith medical asd, inc., portex no epinephrine spinal kit, nepi-nld-15583c-21 failed to work on patient.The bupivicaine spinal ampule in the kit, which is 0.75% in dextrose 8.25% did not produce an effect in the patient.The lot number and expiration date for the spinal kit used is lot# 362254 exp: 03/01/2020.The product was properly stored at controlled room temperature and was intact at time of usage.(b)(6), crna was whom used this kit on our campus.The patient was not complicated and did not have any anatomical issue that lead to spinal insertion complications.Due to complications from kit not working, the patient was forced to receive general anesthesia to finish c-section.Reason for use: cesarean section.Event abated after use stopped: yes.
 
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Brand Name
PORTEX NO EPINEPHRINE, SPINAL KIT
Type of Device
NEEDLE SPINAL, SHORT TERM
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
MDR Report Key8301212
MDR Text Key135695984
Report NumberMW5083651
Device Sequence Number0
Product Code MIA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 01/29/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/01/2020
Device Model NumberNEPI-NLD-15583C-21
Device Lot Number364452
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/01/2019
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age76 YR
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