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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 Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/30/2021
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
During the preparation and the test of the syringe it was observed that the plunger was leaking.It was a liquid leak.The issue was observed prior to use so the device was not used on the patient.So to solve the issue we used another device from another supplier.
 
Event Description
During the preparation and the test of the syringe it was observed that the plunger was leaking.It was a liquid leak.The issue was observed prior to use so the device was not used on the patient.So to solve the issue we used another device from another supplier.
 
Manufacturer Narrative
Qn# (b)(4).A device history record review was performed on the lor syringe with no relevant findings.The customer reported the lor syringe leaked.The customer returned one 10ml plastic lor syringe and lidstock.The syringe was visually examined.Visual examination of the syringe revealed that the syringe appears typical with no observed defects or anomalies.The returned sample was returned to the supplier (preox) for function testing.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.These effective changes did impact product design and material.It should be noted, the returned lor syringe was from the new design.A corrective action is not required at this time.The returned sample was returned to the supplier for function testing.The reported complaint of the lor syringe leaking could not be confirmed.The returned lor syringe was returned to the supplier (preox) for functional testing.When the supplier's test results are available, this complaint will be reopened and the investigation will be updated.A device history record review was performed on the lor syringe with no evidence to suggest a manufacturing related issue.Based on this, the potential cause of this complaint could not be determined.
 
Manufacturer Narrative
Qn# (b)(4).A device history record review was performed on the lor syringe with no relevant findings.The customer reported the lor syringe leaked.The customer returned one 10ml plastic lor syringe and lidstock.The syringe was visually examined.Visual examination of the syringe revealed that the syringe appears typical with no observed defects or anomalies.The returned sample was returned to the supplier (preox) for function testing.According to the supplier, no leak was found with the returned syringe.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.These effective changes did impact product design and material.It should be noted, the returned lor syringe was from the new design.The returned sample was returned to the supplier (preox) for functional testing.No issues were found with the returned sample.The reported complaint of the lor syringe leaking could not be confirmed based on the sample received.The returned lor syringe was returned to the supplier (preox) for functional testing where no issues were found.A device history record review was performed on the lor syringe with no evidence to suggest a manufacturing related issue.Based on the supplier's results, no issues were found with the returned sample.No further action is required at this time.
 
Event Description
During the preparation and the test of the syringe it was observed that the plunger was leaking.It was a liquid leak.The issue was observed prior to use so the device was not used on the patient.So to solve the issue we used another device from another supplier.
 
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Brand Name
EPIDURAL CATHETERIZATION SET
Type of Device
ANESTHESIA CONDUCTION KIT
MDR Report Key11843424
MDR Text Key251430823
Report Number3006425876-2021-00455
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,Followup
Report Date 05/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/23/2022
Device Catalogue NumberJC-05400-B
Device Lot Number71F20M0069
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/08/2021
Date Manufacturer Received07/08/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/03/2020
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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