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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW EPIDURAL CATHETERIZATION KIT; ANESTHESIA CONDUCTION KIT

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ARROW INTERNATIONAL INC. ARROW EPIDURAL CATHETERIZATION KIT; ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number WJ-05401
Device Problem Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/05/2015
Event Type  malfunction  
Manufacturer Narrative
(b)(4).A visual, functional and dimensional inspection could not be performed as no sample was returned for analysis.A device history record review was performed on the kit and the lor syringe with no relevant findings.A review of design history for kit wj-05401 and lor syringe part (b)(4) performed in agile revealed no material changes that could have led to this complaint.A corrective action is not required at this time as the reported complaint could not be confirmed and a root cause could not be identified based upon the information provided and without a sample.Complaint verification testing could not be performed as no sample was returned for analysis.The potential cause of lor syringe leak could not be determined based upon the information provided and without a sample.
 
Event Description
The customer alleges that the lor syringe leaked during use.No patient injury or harm reported.
 
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Brand Name
ARROW EPIDURAL CATHETERIZATION KIT
Type of Device
ANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
312 commerce place
asheboro NC 27203
Manufacturer Contact
margie burton, rn
3015 carrington mill blvd
morrisville, NC 27560
9194334965
MDR Report Key5163113
MDR Text Key28802763
Report Number1036844-2015-00484
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Report Date 10/05/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/31/2016
Device Catalogue NumberWJ-05401
Device Lot Number23F15F0320
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/20/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/06/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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