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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 Consequences Or Impact To Patient (2199)
Event Date 10/15/2020
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
It was reported that the plunger of the syringe leaked during the insertion.The insertion was performed by a doctor in the epidural space.So, the device was replaced with success.There was no delay in the treatment.There was no patient injury, the patient is fine.The syringe was not tested prior to use.
 
Event Description
It was reported that the plunger of the syringe leaked during the insertion.The insertion was performed by a doctor in the epidural space.So, the device was replaced with success.There was no delay in the treatment.There was no patient injury, the patient is fine.The syringe was not tested prior to use.
 
Manufacturer Narrative
(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 four sealed representative kits from the same lot# as reported on the complaint for investigation.The actual complaint sample was not returned.The returned kits were opened and the 10ml plastic lor syringes were removed and were visually examined.Visual examination of the syringes revealed that the syringes appear typical with no observed defects or anomalies.The returned samples were returned to the supplier (preox) for function testing.According to the supplier, no leak was found with none of the returned syringes.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 syringes were from the new design.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 visually inspected with no issues.The syringes were returned to the supplier (preox) where the syringes were functionally tested with no issue found.
 
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Brand Name
EPIDURAL CATHETERIZATION SET
Type of Device
ANESTHESIA CONDUCTION KIT
MDR Report Key10755174
MDR Text Key213664227
Report Number3006425876-2020-00935
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 Received10/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/20/2022
Device Model NumberIPN046311
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
Treatment
N/A.
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