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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
Model Number IPN046311
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Information (3190)
Event Date 12/01/2019
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
Customer reported that the plunger of the syringe show a certain tolerance so that the plunger is very loose in the syringe and has a lot of space.
 
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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 Key9483317
MDR Text Key179439610
Report Number3006425876-2019-01067
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K103658
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/05/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/17/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/12/2021
Device Model NumberIPN046311
Device Catalogue NumberJC-05400-B
Device Lot Number71F19H2034
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/17/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/21/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/23/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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