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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 Failure to Advance (2524)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/20/2019
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 the syringe of the set has no resistance because a leak is present, thus the identification of the epidural space is difficult.
 
Event Description
It was reported that the syringe of the set has no resistance because a leak is present, thus the identification of the epidural space is difficult.
 
Manufacturer Narrative
(b)(4). A device history record review was performed on the lor syringe with no relevant findings. 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 NameEPIDURAL CATHETERIZATION SET
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key8709016
MDR Text Key148334836
Report Number3006425876-2019-00400
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 company representative,foreig
Type of Report Initial,Followup
Report Date 05/21/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/18/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/21/2021
Device Catalogue NumberJC-05400-B
Device Lot Number71F19C0265
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/05/2019
Is This a Reprocessed and Reused Single-Use Device? No

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