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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANESTHESIA 17GAX18CM DURASAFE; ANESTHESIA TRAY
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ANESTHESIA 17GAX18CM DURASAFE; ANESTHESIA TRAY 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 01/24/2021
Event Type  malfunction  
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
 
Event Description
It was reported that 2 anesthesia 17gax18cm durasafe experienced leakage.The following information was provided by the initial reporter: after the customer opened the package, when using the syringe, he found that the liquid would leak from the rubber stopper.
 
Event Description
It was reported that 2 anesthesia 17gax18cm durasafe experienced leakage.The following information was provided by the initial reporter: after the customer opened the package, when using the syringe, he found that the liquid would leak from the rubber stopper.
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-02-01.H6: investigation summary: a device history review was conducted for lot number 9196637.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 returned sample was reviewed by our team of quality engineers, they were able to identify deformation in the rubber stopper of the syringe that were consistent with known deformations in the raw material.These imperfections are evaluated and segregated by trained inspection teams.The root cause for this event is related to the manual evaluation of incoming materials and is subject to human error.H3 other text : see h10.
 
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Brand Name
ANESTHESIA 17GAX18CM DURASAFE
Type of Device
ANESTHESIA TRAY
MDR Report Key11342887
MDR Text Key243986774
Report Number3006948883-2021-00240
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 Received02/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number401622
Device Lot Number9196637
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/01/2021
Date Manufacturer Received05/18/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/15/2019
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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