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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW CATHETER, CONDUCTION, ANESTHETIC

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TELEFLEX INCORPORATED ARROW CATHETER, CONDUCTION, ANESTHETIC Back to Search Results
Lot Number 23F21A0064
Device Problems Leak/Splash (1354); Material Separation (1562); Defective Component (2292)
Patient Problem Insufficient Information (4580)
Event Date 05/15/2021
Event Type  malfunction  
Event Description
Arrow flextip plus(r) epidural catheterization kit was opened by health care provider. The lidocaine 1% and 10ml saline solution vials were empty, and the tops popped off. No liquid was found in the tray.
 
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Brand NameARROW
Type of DeviceCATHETER, CONDUCTION, ANESTHETIC
Manufacturer (Section D)
TELEFLEX INCORPORATED
po box 12600
durham NC 27709
MDR Report Key11946146
MDR Text Key254506204
Report Number11946146
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial
Report Date 05/24/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number23F21A0064
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/24/2021
Event Location No Information
Date Report to Manufacturer06/07/2021
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 Unkown

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