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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC.; ANESTHESIA CONDUCTION KIT
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SMITHS MEDICAL ASD, INC.; ANESTHESIA CONDUCTION KIT Back to Search Results
Device Problem Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/27/2020
Event Type  malfunction  
Event Description
It was reported that the suspect device was bent when removed from the stylet from the spinal needle.No patient injury was reported.
 
Manufacturer Narrative
A device history record (dhr) review was conducted which indicated all inspection were completed and no issues were noted during manufacture.Upon observing the returned product, it was confirmed that the stylet was bent at the base of the cap.The reported event was confirmed; however, the root cause could not be established.The manufacturer will continue to monitor the future occurrence status.No product information has been provided to date.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# 617147.
 
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Type of Device
ANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
10 bowman dr.
keene NH 03431
Manufacturer (Section G)
SMITHS MEDICAL ASD, INC.
10 bowman dr.
keene NH 03431
Manufacturer Contact
jim vegel
6000 nathan lane north
3-10-15, hakata station east,
minneapolis, MN 55442
MDR Report Key15322321
MDR Text Key305366967
Report Number3012307300-2022-16824
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 08/30/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/30/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/05/2020
Was the Report Sent to FDA? No
Date Manufacturer Received05/27/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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