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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 IPN046313
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/24/2020
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 there is a lack of pressure in the lor syringe.Further information indicates that the syringe leaked liquid and around 10 patients were concerned but he is not able to provide the exact quantity.There was no patient consequence, no device available for investigation.
 
Event Description
It was reported that there is a lack of pressure in the lor syringe.Further information indicates that the syringe leaked liquid and around 10 patients were concerned but he is not able to provide the exact quantity.There was no patient consequence, no device available for investigation.
 
Manufacturer Narrative
Qn#(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-051699 (released 03-dec-2018), supplier (preox) made the following changes: kz-05501-002 luer plastic lor syringe: a.Changed plunger material from profax 535 to profax 531.B.Changed to new plunger tool.C.Changed to new mold for blue stopper.D.Changed molding location for the plunger and the blue stopper as follows.- plunger: from fleimaplastic in germany to gpe, germany - blue stopper: from et, germany to psilkon, germany these effective changes did impact product design and material.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.
 
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Brand Name
EPIDURAL CATHETERIZATION SET
Type of Device
ANESTHESIA CONDUCTION KIT
MDR Report Key9695867
MDR Text Key180325522
Report Number3006425876-2020-00166
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 01/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/11/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberIPN046313
Device Catalogue NumberJC-05400-DCS
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received03/11/2020
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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