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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION SET; ANESTHESIA CONDUCTION KIT
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ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION SET; ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number JC-05400-B
Device Problem Mechanics Altered (2984)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/27/2019
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 inserting the peridural catheter, the needle included in the kit was not sealed: air vacuum during aspiration test after insertion of catheter.Opened a new kit and no problem with the new needle.
 
Event Description
It was reported that while inserting the peridural catheter, the needle included in the kit was not sealed: air vacuum during aspiration test after insertion of catheter.Opened a new kit and no problem with the new needle.
 
Manufacturer Narrative
Qn#(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-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 was performed on the lor syringe with no evidence to suggest a manufacturing related cause.Therefore, the potential cause of the lor syringe leaking 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
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key9120020
MDR Text Key160130503
Report Number3006425876-2019-00664
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,u
Type of Report Initial,Followup
Report Date 08/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/25/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/29/2021
Device Catalogue NumberJC-05400-B
Device Lot Number71F19E0689
Was Device Available for Evaluation? No
Date Manufacturer Received10/14/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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