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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANESTHESIA 17GAX18CM DURASAFE; ANESTHESIA CONDUCTION KIT
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ANESTHESIA 17GAX18CM DURASAFE; ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number 401622
Device Problem Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/28/2020
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 178 anesthesia 17gax18cm durasafe experienced leakage at the connection site.The following information was provided by the initial reporter: when using the anesthesia kit, it was found that the syringe was connected to the spinal anesthesia needle to inject the medicine leakage.After the hospital department staff used the other brand syringe to test, no leakage was found.
 
Manufacturer Narrative
H.6.Investigation: a device history review was conducted for lot number 9066580.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.A sample could not be obtained for evaluation and testing; in lieu of the affected device, functional testing was performed on retention samples for this lot, the results of these show that the tested units performed within product specifications.Unfortunately without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.
 
Event Description
It was reported that 178 anesthesia 17gax18cm durasafe experienced leakage at the connection site.The following information was provided by the initial reporter: when using the anesthesia kit, it was found that the syringe was connected to the spinal anesthesia needle to inject the medicine leakage.After the hospital department staff used the other brand syringe to test, no leakage was found.
 
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Brand Name
ANESTHESIA 17GAX18CM DURASAFE
Type of Device
ANESTHESIA CONDUCTION KIT
MDR Report Key10909085
MDR Text Key226854373
Report Number3006948883-2020-00849
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 12/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/26/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date03/22/2024
Device Catalogue Number401622
Device Lot Number9077580
Was Device Available for Evaluation? No
Date Manufacturer Received12/09/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/18/2019
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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