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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW ANESTHESIA CONDUCTION KIT

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TELEFLEX INCORPORATED ARROW ANESTHESIA CONDUCTION KIT Back to Search Results
Device Problems Leak/Splash (1354); Material Puncture/Hole (1504)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/20/2021
Event Type  malfunction  
Event Description
Arrow® flextip plus® epidural catheter was flushed with test dose. A small hole leaking test dose was noted at about the 15 mark. Catheter was not inserted into patient.
 
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Brand NameARROW
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
TELEFLEX INCORPORATED
po box 12600
durham NC 27709
MDR Report Key11919382
MDR Text Key253721054
Report Number11919382
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 05/17/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/17/2021
Event Location No Information
Date Report to Manufacturer06/02/2021
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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