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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX SPINAL SINGLE SHOT TRAYS ANESTHESIA CONDUCTION KIT

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SMITHS MEDICAL ASD, INC. PORTEX SPINAL SINGLE SHOT TRAYS ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number NEPI-49661-25
Device Problems Defective Device (2588); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem Pain (1994)
Event Date 08/07/2018
Event Type  Injury  
Manufacturer Narrative
Device evaluation in progress.
 
Event Description
It was reported that the bupivacaine was not working again on the patient who was giving birth. The patient experienced a lot of pain during the delivery and had to be put under anesthesia. No further complications were reported in connection with this incident.
 
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Brand NamePORTEX SPINAL SINGLE SHOT TRAYS
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer (Section G)
SMITHS MEDICAL NORTH AMERICA
10 bowman drive
keene OH 03431 0724
Manufacturer Contact
dave halverson
1265 grey fox road
st. paul, MN 55112
7633833310
MDR Report Key7891757
MDR Text Key120821028
Report Number3012307300-2018-03725
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 Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial
Report Date 09/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/01/2020
Device Catalogue NumberNEPI-49661-25
Device Lot Number3624023
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/04/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/21/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/29/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 09/19/2018 Patient Sequence Number: 1
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