Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EPIDURAL CATHETERIZATION SET; ANESTHESIA CONDUCTION KIT
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 09/21/2020
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 while we were using the epidural kit, we had an incident with the lor syringe.The physiological serum was leaking from the plunger instead of getting out from the needle.So, we used another kit on the patient.It was an isolated incident.
 
Manufacturer Narrative
(b)(4).A device history record review was performed on the lor syringe with no relevant findings.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.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.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.
 
Event Description
It was reported that while we were using the epidural kit, we had an incident with the lor syringe.The physiological serum was leaking from the plunger instead of getting out from the needle.So, we used another kit on the patient.It was an isolated incident.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
EPIDURAL CATHETERIZATION SET
Type of Device
ANESTHESIA CONDUCTION KIT
MDR Report Key10670349
MDR Text Key211757744
Report Number3006425876-2020-00880
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 09/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/13/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/16/2022
Device Model NumberIPN046311
Device Catalogue NumberJC-05400-B
Device Lot Number71F20B2207
Was Device Available for Evaluation? No
Date Manufacturer Received11/12/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/27/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
-
-