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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
Model Number IPN038423
Device Problems Material Twisted/Bent (2981); Physical Resistance/Sticking (4012)
Patient Problem No Information (3190)
Event Date 03/27/2019
Event Type  malfunction  
Event Description
A patient was admitted for labor and delivery. The anesthesia provider tried to place an epidural catheter. Minimal resistance was met. After loss of resistance, the catheter failed to thread, and the needle was removed. At that time, it was noted that the tip of the tuohy needle was bent forward, partially occluding the orifice. It is uncertain whether the tip was bent prior to insertion or during placement. There is concern that the tip should not bend and can create a safety issue as it can shear the catheter upon threading. A similar event reportedly occurred with a different patient in the cardiac operating room (o. R. ) recently. We are unsure if there is an issue with this lot. The patient required general anesthesia for a c-section.
 
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Brand NameARROW
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
TELEFLEX INCORPORATED
50 plantation drive
jaffrey NH 03452
MDR Report Key8568906
MDR Text Key143712603
Report Number8568906
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial,Followup
Report Date 04/08/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/01/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIPN038423
Device Catalogue NumberASK-05500-JHH1
Device Lot Number23F18J0108
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/08/2019
Event Location Hospital
Date Report to Manufacturer05/01/2019
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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