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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 Fluid Leak (1250)
Patient Problem Headache (1880)
Event Date 09/15/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The device investigation is pending. Teleflex will continue to monitor and trend related events.
 
Event Description
It was reported that while performing an epidural analgesia the syringe was not sealed properly it caused difficulties locating the epidural zone. There was fluid leakage. It seems the plunger was not sealed, and serum leaked between the syringe and the plunger. Clinical consequences: dura-mater breach - beginning of cephalgia on (b)(6) 2019 - scheduled blood patch on (b)(6) 2019. The blood patch was performed according to addition information.
 
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Brand NameEPIDURAL CATHETERIZATION SET
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL CR, A.S.
jamska 2359/47
zdar nad sazavou 591 0 1
EZ 591 01
Manufacturer Contact
jasmine brown
3015 carrington mill blvd
morrisville, NC 27560
9193614124
MDR Report Key9172952
MDR Text Key161739125
Report Number3006425876-2019-00764
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K103658
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/09/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/18/2021
Device Catalogue NumberJC-05400-B
Device Lot Number71F19C2866
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/27/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/04/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/29/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 10/09/2019 Patient Sequence Number: 1
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