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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANESTHESIA 17GAX18CM DURASAFE; ANESTHESIA KITS
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ANESTHESIA 17GAX18CM DURASAFE; ANESTHESIA KITS Back to Search Results
Catalog Number 401622
Device Problem Leak/Splash (1354)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/20/2021
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.(b)(4).
 
Event Description
It was reported that anesthesia 17gax18cm durasafe was damaged.This occurred on 5 occasions.The following information was provided by the initial reporter: there were about 5 cases of complaints, and customers reported to dealers that the blue parts in the pictures were reversed in the near future.
 
Event Description
It was reported that anesthesia 17gax18cm durasafe was damaged.This occurred on 5 occasions.The following information was provided by the initial reporter: there were about 5 cases of complaints, and customers reported to dealers that the blue parts in the pictures were reversed in the near future.
 
Manufacturer Narrative
H6: investigation summary a device history review was conducted for lot number 9294542.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.Based on the provided photograph our engineers have determined the root cause to be related to the manual assembly process.Our supplier has been notified of the situation.To prevent a reoccurrence of this event our supplier has installed a fixture in the manufacturing line to verify correct assembly of the component.H3 other text : see h10.
 
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Brand Name
ANESTHESIA 17GAX18CM DURASAFE
Type of Device
ANESTHESIA KITS
MDR Report Key11336206
MDR Text Key232196880
Report Number3006948883-2021-00237
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 04/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number401622
Device Lot Number9294542
Was Device Available for Evaluation? No
Date Manufacturer Received04/27/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/21/2019
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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