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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EPIDURAL CATHETERIZATION KIT: 19 GA. X 3; ANESTHESIA CONDUCTION KIT
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EPIDURAL CATHETERIZATION KIT: 19 GA. X 3; ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number ASK-05501-SM
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/07/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
 
Event Description
Reported issue: the doctor was inserting an epidural into a laboring patient.When she opened the arrow kit, she noticed the 1.5% lidocaine ampule was broken and empty of medication.In addition, when she inspected the glass syringe (loss of resistance syringe) it was stuck (unable to move plunger).The entire kit was discarded by the md and a new one was open.The new kit had no issues noted and the patient received her epidural without incident.
 
Manufacturer Narrative
Qn#(b)(4).A device history record review was performed on the epidural kit and the lidocaine w/epinephrine ampule with no relevant findings.A corrective action is not required at this time as a potential root cause could not be determined based upon the information provided and without a sample.Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed on the epidural kit and the lidocaine w/epinephrine with no evidence to suggest a manufacturing related cause.The potential cause of the broken ampule could not be determined based upon the information provided and without a sample.
 
Event Description
Reported issue: the doctor was inserting an epidural into a laboring patient.When she opened the arrow kit, she noticed the 1.5% lidocaine ampule was broken and empty of medication.In addition, when she inspected the glass syringe (loss of resistance syringe) it was stuck (unable to move plunger).The entire kit was discarded by the md and a new one was open.The new kit had no issues noted and the patient received her epidural without incident.
 
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Brand Name
EPIDURAL CATHETERIZATION KIT: 19 GA. X 3
Type of Device
ANESTHESIA CONDUCTION KIT
MDR Report Key10750761
MDR Text Key213655079
Report Number1036844-2020-00263
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
PMA/PMN Number
K103658
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 10/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/31/2021
Device Catalogue NumberASK-05501-SM
Device Lot Number23F20B0284
Was Device Available for Evaluation? No
Date Manufacturer Received11/25/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/19/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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