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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EPIDURAL CATHETERIZATION SET; ANESTHESIA CONDUCTION KIT
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EPIDURAL CATHETERIZATION SET; ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number JC-05400-B
Device Problem Difficult to Advance (2920)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/15/2020
Event Type  malfunction  
Manufacturer Narrative
Qn#: (b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
 
Event Description
It was reported that the epidural was used while giving birth (female patient).The bevel of the needle appeared to be very slightly longer than usual and dull.3 different doctors tried to insert the needle in the epidural space with no success.The device was replaced without success.There was a delay in the treatment.Consequence for the patient: occurrence of the claude bernard-horner syndrome.The syringe was not tested/checked prior to use.The patient is fine now.Additional information: the patient was diagnosed with claude bernard-horner syndrome because after the incident she presented a fac ial symptomatology such as tosis of the eyelids and myosis.The diagnosis was made as related to the multiple spinal punctures when injecting the test dose.No medical intervention required.The device integrity had been checked prior to use.
 
Event Description
It was reported that the epidural was used while giving birth (female patient).The bevel of the needle appeared to be very slightly longer than usual and dull.3 different doctors tried to insert the needle in the epidural space with no success.The device was replaced without success.There was a delay in the treatment.Consequence for the patient: occurrence of the claude bernard-horner syndrome.The syringe was not tested/checked prior to use.The patient is fine now.Additional information: the patient was diagnosed with claude bernard-horner syndrome because after the incident she presented a fac ial symptomatology such as tosis of the eyelids and myosis.The diagnosis was made as related to the multiple spinal punctures when injecting the test dose.No medical intervention required.The device integrity had been checked prior to use.
 
Manufacturer Narrative
Qn# (b)(4).A device history record review was performed on the epidural needle with no relevant findings.The customer reported the epidural needle was difficult to advance into the epidural space.The customer returned four sealed representative kits from the same lot # as reported on the complaint ((b)(4)) for investigation.The actual complaint sample was not returned.The returned kits were opened, and the epidural needles were removed and were visually examined.Visual examination of all four returned needles revealed, the needles looked typical with the bevel appearing to be polished and smooth with no observed burrs as well as the needle's cannula appearing to be typical.Since the needles were returned from sealed representative samples.A functional test was performed by attempting to thread a lab inventory catheter through the returned epidural needles.The catheter was thread at the distal end and would thread through each epidural needle with no resistance met.A drag test was performed per pip-013, rev 3 using a lab inventory catheter and returned needles with a weight (ref-002579).The catheter could thread through each of the returned needles with no resistance met.The returned needles passed the drag test.A design history review was performed for kit # jc-05400-b and part # rz-05400-006 as a part of this complaint investigation.There have been no material changes for these parts during the last two years that could have led to this complaint.Also, penetration and ping data was requested from the manufacturing site (zdar).According to the manufacturing site, penetration data from supplier nor testing the penetration at the manufacturing site during incoming inspection is not required.Based on this, the penetration and ping data is not available.A corrective action is not required at this time as the complaint could not be confirmed based upon the information provided and without the actual complaint sample.The representative samples received were functionally tested and visually inspected with no issue found.The reported complaint of the epidural needle was difficult to advance into the epidural space could not be confirmed based on the sample received.The actual complaint sample was not returned.Four representative samples were returned.Visual examination of the returned needles revealed no observed defects or anomalies.Since representative samples were returned, functional testing was performed on the returned needles.A lab inventory catheter could be thread through all returned needles with no resistance met.The returned needles passed a functional drag test.A device history record review was performed on the needle with no relevant findings.Penetration and ping data were requested from the manufacturing site; however, it was not available.A potential root cause could not be determined based upon the information provided or without the actual complaint sample.
 
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Brand Name
EPIDURAL CATHETERIZATION SET
Type of Device
ANESTHESIA CONDUCTION KIT
MDR Report Key10793038
MDR Text Key214820663
Report Number3006425876-2020-00934
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 foreign,health professional
Type of Report Initial,Followup
Report Date 10/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/05/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date06/20/2022
Device Catalogue NumberJC-05400-B
Device Lot Number71F20F2332
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/02/2020
Date Manufacturer Received11/30/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/30/2020
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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