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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL, INC. FLEXTIP PLUS ANESTHESIA CONDUCTION KIT

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ARROW INTERNATIONAL, INC. FLEXTIP PLUS ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number ASK-05400-SM
Device Problem Unsealed Device Packaging (1444)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/01/2016
Event Type  malfunction  
Event Description
The patient was about to undergo a lumbar epidural procedure. Upon opening the epidural spinal tray, it was discovered the lidocaine vial was already opened.
 
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Brand NameFLEXTIP PLUS
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
ARROW INTERNATIONAL, INC.
11245 n. distribution cove
olive branch MS 38654
MDR Report Key6103046
MDR Text Key59934230
Report Number6103046
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 User Facility
Reporter Occupation
Type of Report Initial
Report Date 08/02/2016,08/16/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/15/2016
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2017
Device Catalogue NumberASK-05400-SM
Device Lot Number23F16D0378
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/02/2016
Event Location Hospital
Date Report to Manufacturer08/02/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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