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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANESTHESIA 17GAX18CM DURASAFE; NEEDLE SET
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ANESTHESIA 17GAX18CM DURASAFE; NEEDLE SET Back to Search Results
Catalog Number 401622
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/29/2021
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.
 
Event Description
It was reported that the anesthesia 17gax18cm durasafe experienced leakage.The following information was provided by the initial reporter: received a notice from teacher of the anesthesiology department, the complaint was mainly about the leakage of low-resistance syringes during use (the lumbar anaesthesia needle and syringes are often not connected closely, so there is complete leakage of air, and no resistance can be detected).
 
Manufacturer Narrative
H.6.Investigation: a device history review was conducted for lot number 0311824.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, visual analysis was performed on retention samples for this lot, the retained devices were found to be free of any damage or other abnormalities.Unfortunately without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.H3 other text : see h.10.
 
Event Description
It was reported that the anesthesia 17gax18cm durasafe experienced leakage.The following information was provided by the initial reporter: received a notice from teacher of the anesthesiology department, the complaint was mainly about the leakage of low-resistance syringes during use (the lumbar anaesthesia needle and syringes are often not connected closely, so there is complete leakage of air, and no resistance can be detected).
 
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Brand Name
ANESTHESIA 17GAX18CM DURASAFE
Type of Device
NEEDLE SET
MDR Report Key12250261
MDR Text Key266179214
Report Number3006948883-2021-00846
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 08/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number401622
Device Lot Number0311824
Was Device Available for Evaluation? No
Date Manufacturer Received08/17/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/06/2020
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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