• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SMITHS MEDICAL ASD, INC. PORTEX® SPINAL ANESTHESIA TRAYS ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number D-15597-20
Device Problem Failure to Infuse (2340)
Patient Problem Underdose (2542)
Event Type  Injury  
Manufacturer Narrative
Smiths medical did not receive samples for analysis. However, the device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution. No issues were identified that would have impacted this event. Assay testing was performed by the supplier prior to release of bupivacaine, lidocaine, and epinephrine with all being within specification. Review of the sterilization certificates revealed that the product was processed according to validated specification requirements and parameters. Records revealed that the supplied drugs components continue to meet potency specifications since they are periodically monitored. Complaint history review showed that it does not indicate any upward trends for the drug lot numbers, reported in this complaint. Based on evidence, no product quality problem could be confirmed. Possible root causes of lack of effect may also be administration technique or patient anatomical variations, including pathological or psychological factors. No corrective action will be conducted at this time will continued to be reviewed.
 
Manufacturer Narrative
Potential event dates: (b)(6) 2017. Potential lot numbers: 3373455, 3371993, 3468284, 3455343.
 
Event Description
Due to the intubation, the reporter noted that the patient had increased risk of newborn respiratory failure. The reporter was unaware of any complication with the newborn.
 
Event Description
Information was received indicating that a smiths medical portex® spinal anesthesia tray that was used for spinal anesthesia during a c-section, failed to work. The spinal was reported to be placed correctly with visible csf return. Subsequently, the patient required airway intubation to manage to the delivery of the baby. As a result, it was reported that during intubation, the baby received some anesthesia and was required to be transferred to higher care. No adverse effects were reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePORTEX® SPINAL ANESTHESIA 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 NH 03431
Manufacturer Contact
dave halverson
6000 nathan lane n
minneapolis, MN 55442
7633833310
MDR Report Key7160229
MDR Text Key109255685
Report Number3012307300-2017-02747
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
E332605
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/03/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberD-15597-20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/25/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/03/2018 Patient Sequence Number: 1
-
-