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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-E
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/04/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The device has not been returned for investigation at this time. The manufacturer will continue to monitor and trend related events.
 
Event Description
Reported event: it was reported that the connector loosens time after time at the catheter end. The catheter was replaced. The patient's condition was reported as fine.
 
Manufacturer Narrative
(b)(4). A device history record review was performed on the snaplock adapter and epidural catheter with no relevant findings. A corrective action is not required at this time as a potential cause could not be determined based upon the information provided and without a sample. Complaint verification testing could not be performed as no sample was returned for analysis. A device history record review was performed on the snaplock adapter and epidural catheter with no evidence to suggest a manufacturing related cause. Therefore, the potential cause of the catheter disconnecting from the snaplock adapter could not be determined based upon the information provided and without a sample.
 
Event Description
Reported event: it was reported that the connector loosens time after time at the catheter end. The catheter was replaced. The patient's condition was reported as fine.
 
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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 Key5644338
MDR Text Key44894407
Report Number3006425876-2016-00110
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeNL
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/13/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/10/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/31/2017
Device Catalogue NumberJC-05400-E
Device Lot Number71F15G1079
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/17/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/20/2015
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: 05/10/2016 Patient Sequence Number: 1
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