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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. EPIDURAL ANESTHESIA KIT; ANESTHESIA CONDUCTION KIT
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ARROW INTERNATIONAL INC. EPIDURAL ANESTHESIA KIT; ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number ASK-03000-MN
Device Problem Break (1069)
Patient Problem No Patient Involvement (2645)
Event Date 06/10/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The kit has not been returned for investigation.Teleflex will continue to monitor and trend related events.
 
Event Description
It was reported that the new trays are not keeping items in order and breaking vials.When they signed the contract for the custom kit, they did not sign for the same outer tray that is being sent.They want they soft trays replaced with the sturdy plastic tray they signed up for.
 
Event Description
It was reported that the new trays are not keeping items in order and breaking vials.When they signed the contract for the custom kit, they did not sign for the same outer tray that is being sent.They want they soft trays replaced with the sturdy plastic tray they signed up for.
 
Manufacturer Narrative
(b)(4).A device history record review was performed with a potentially relevant finding.A nonconformance was initiated only as a general nc to temporarily allow certain finished good part numbers to be packaged with additional gauze in order to better secure medication ampules in the inner tray.Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed with a potentially relevant finding.Based on the information provided, the potential root cause of this issue is design related.A capa was initiated to further investigate this complaint issue.
 
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Brand Name
EPIDURAL ANESTHESIA KIT
Type of Device
ANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key8813219
MDR Text Key151776741
Report Number1036844-2019-00847
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
PMA/PMN Number
K122027
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 07/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/22/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/30/2020
Device Catalogue NumberASK-03000-MN
Device Lot Number23F19C0306
Was Device Available for Evaluation? No
Date Manufacturer Received08/22/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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