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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL ARROW® EPIDURAL CATHETERIZATION KIT WITH FLEXTIP PLUS® CATHETER ANESTHESIA CONDUCTION KIT

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TELEFLEX MEDICAL ARROW® EPIDURAL CATHETERIZATION KIT WITH FLEXTIP PLUS® CATHETER ANESTHESIA CONDUCTION KIT Back to Search Results
Model Number ASK-05502-MGH
Device Problems Fracture (1260); Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/15/2017
Event Type  malfunction  
Event Description
Fractured epidural catheter: mds saw the patient on post operative day 2 and noted the epidural was leaking at the insertion site. They removed it and noted that the plastic catheter was fractured but did not sever because of the metal coil that encases the epidural tube. No portion of the catheter was retained. It is unclear when the catheter fractured during use.
 
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Brand NameARROW® EPIDURAL CATHETERIZATION KIT WITH FLEXTIP PLUS® CATHETER
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
TELEFLEX MEDICAL
3015 carrington mill blvd.
morrisville NC 27560
MDR Report Key6463459
MDR Text Key71879772
Report Number6463459
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 03/22/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/06/2017
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberASK-05502-MGH
Device Catalogue NumberASK-05502-MGH
Device Lot Number23F16H1048
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/22/2017
Event Location Hospital
Date Report to Manufacturer03/22/2017
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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