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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANESTHESIA 17GAX18CM DURASAFE; ADAPTER

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ANESTHESIA 17GAX18CM DURASAFE; ADAPTER Back to Search Results
Catalog Number 401622
Device Problem Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/19/2020
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 leaked during use.The following information was provided by the initial reporter: when anesthesiologists used epidural catheters, the medicine was injected after catheterization, there was leakage at the syringe joint of the catheters, it was resulting in the leakage of the liquid and there was the gap of the dose.
 
Manufacturer Narrative
Investigation summary a device history review was conducted for lot number 9046560.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.Retention samples were selected from bd inventory for evaluation/testing and upon completion, no issues were observed.Unfortunately a sample could not be obtained for evaluation and testing.Without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.Bd will continue to monitor this issue and encourages you to submit your sample for review.
 
Event Description
It was reported that anesthesia 17gax18cm durasafe leaked during use.The following information was provided by the initial reporter: when anesthesiologists used epidural catheters, the medicine was injected after catheterization, there was leakage at the syringe joint of the catheters, it was resulting in the leakage of the liquid and there was the gap of the dose.
 
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Brand Name
ANESTHESIA 17GAX18CM DURASAFE
Type of Device
ADAPTER
MDR Report Key9812566
MDR Text Key188672802
Report Number3006948883-2020-00080
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
PMA/PMN Number
N/A
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 03/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date03/02/2024
Device Catalogue Number401622
Device Lot Number9046560
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 02/19/2020
Initial Date FDA Received03/10/2020
Supplement Dates Manufacturer Received02/19/2020
Supplement Dates FDA Received03/23/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/15/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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