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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
Model Number IPN046311
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/29/2020
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
Anesthesiologist from maternity department contacted me last week regarding epidural kit jc-05400-b: the lor syringe leaks when used as per ifu.The anesthesiologist did a demonstration with brand new syringe: i could observe the leakage.I have the syringe from test available for investigation.Unfortunately, i do not know the lot number of this specific syringe.Nevertheless, the anesthesiologist advised me yesterday that the same issue was observed on several lots currently at the maternity.Those lots are 71f20h2136, 71f20j2236, 71f20e0691 and 71f20e0379.Additional information: the syringe was being used for lumbar puncture l3l4 in a sitting position.Loss of resistance with liquid mandrel using the loss of resistance syringe from the kit arrow filled with saline solution nacl 0.9% up to the 10ml graduation.Before the procedure no test was performed to verify if the syringe is properly working.If the packaging of the kit is intact it is deemed to be sterile and flawless.There is no false positive test.At 5cm deep clear loss of resistance testifying to the penetration into space epidural; at the same time leakage of saline solution between syringe which surprised the user.
 
Manufacturer Narrative
(b)(4).A device history record review could not be performed as no lot number was provided by the customer.A design history review was performed for part # kz-05501-002 as a part of this complaint investigation.Per eco-057562 (released 12-mar-2020), supplier (preox) made the following changes: optional component materials/mold locations: option 1: barrel: polypropylene - profax pf-535 lyondell-basell; plunger: polypropylene 100-ga12 ineos olefins & polymers (molded at fleima plastic); blue stopper: silicone rubber (molded at et elastomer technik).Option 2: barrel: polypropylene - profax pf-535 lyondell-basell; plunger: polypropylene profax pf-531 lyondell-basell (molded at gpe); blue stopper: silicone rubber (molded at psilkon).Lubricant: - the i.D.Of the barrel lubricated w/ medical grade silicone; (polydimethylsiloxan) and amount will not exceed 0.25mg per sq centimeter.A corrective action is not required at this time as the root cause for this complaint investigation could not be determined based upon the information provided and without the actual sample.Complaint verification testing could not be performed as no sample was provided for analysis.A device history record review could not be performed as no lot number was provided by the customer.Therefore, the potential cause of this complaint could not be determined based upon the information provided and without the sample.
 
Event Description
Anesthesiologist from maternity department contacted me last week regarding epidural kit jc-05400-b: the lor syringe leaks when used as per ifu.The anesthesiologist did a demonstration with brand new syringe: i could observe the leakage.I have the syringe from test available for investigation.Unfortunately, i do not know the lot number of this specific syringe.Nevertheless, the anesthesiologist advised me yesterday that the same issue was observed on several lots currently at the maternity.Those lots are 71f20h2136, 71f20j2236, 71f20e0691 and 71f20e0379.Additional information: the syringe was being used for lumbar puncture l3l4 in a sitting position.Loss of resistance with liquid mandrel using the loss of resistance syringe from the kit arrow filled with saline solution nacl 0.9% up to the 10ml graduation.Before the procedure no test was performed to verify if the syringe is properly working.If the packaging of the kit is intact it is deemed to be sterile and flawless.There is no false positive test.At 5cm deep clear loss of resistance testifying to the penetration into space epidural; at the same time leakage of saline solution between syringe which surprised the user.
 
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Brand Name
EPIDURAL CATHETERIZATION SET
Type of Device
ANESTHESIA CONDUCTION KIT
MDR Report Key11244941
MDR Text Key232759673
Report Number3006425876-2021-00046
Device Sequence Number1
Product Code CAZ
UDI-Device Identifier40801902029674
UDI-Public40801902029674
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 01/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberIPN046311
Device Catalogue NumberJC-05400-B
Device Lot NumberUNKNWON
Was Device Available for Evaluation? No
Date Manufacturer Received02/19/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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