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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANESTHESIA 17GAX18CM DURASAFE; ANESTHESIA KIT
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ANESTHESIA 17GAX18CM DURASAFE; ANESTHESIA KIT Back to Search Results
Catalog Number 401622
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/05/2021
Event Type  malfunction  
Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that anesthesia 17gax18cm durasafe had foreign matter.The following information was provided by the initial reporter: the department of anesthesiology.Foreign matter were found during use.
 
Event Description
It was reported that anesthesia 17gax18cm durasafe had foreign matter.The following information was provided by the initial reporter: the department of anesthesiology.Foreign matter were found during use.
 
Manufacturer Narrative
H6: investigation summary: a device history review was conducted for lot number 0255551.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.Additionally, the sample submitted by your facility, was subjected to functional testing, by our team of quality engineers.Results of this testing were able to positively identify the foreign material as cotton residue from the cutting and folding process.The presence of this material is controlled by the manual removal by the manufacturing operator.H3 other text : see h10.
 
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Brand Name
ANESTHESIA 17GAX18CM DURASAFE
Type of Device
ANESTHESIA KIT
MDR Report Key11593124
MDR Text Key267331169
Report Number3006948883-2021-00338
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 05/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number401622
Device Lot Number0259551
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/14/2021
Date Manufacturer Received05/18/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/15/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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