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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL FLEXTIP PLUS EPIDURAL CATHETERIZATION KIT FLEXTIP PLUS EPIDURAL KIT

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ARROW INTERNATIONAL FLEXTIP PLUS EPIDURAL CATHETERIZATION KIT FLEXTIP PLUS EPIDURAL KIT Back to Search Results
Model Number SJ-05501
Device Problems Detachment Of Device Component (1104); Fracture (1260)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 02/10/2017
Event Type  malfunction  
Event Description
An obstetric patient had a continuous infusion labor epidural using an arrow brand catheter from a ready-made insertion kit supplied by arrow. No problems were encountered during insertion or use of the catheter for the labor, but upon removal by the registered nurse, who was highly experienced with the removal of epidural catheters, the catheter fractured. This resulted in approximately 3. 5cm of the distal-most part of the catheter remaining in the epidural space in front of the body of l4, with the most distal part of the catheter positioned in the right of the epidural space. Patient had a labor epidural infusion on (b)(6) 2017. Upon removal of the catheter later the same day, the catheter fractured, and 3. 5cm remained in the patient's body. Date of use: one day. Diagnosis or reason for use: pain relief for labor. Is the product compounded: no. Is the product over-the-counter: no.
 
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Brand NameFLEXTIP PLUS EPIDURAL CATHETERIZATION KIT
Type of DeviceFLEXTIP PLUS EPIDURAL KIT
Manufacturer (Section D)
ARROW INTERNATIONAL
reading PA 19605
MDR Report Key6352556
MDR Text Key68272541
Report NumberMW5068031
Device Sequence Number1
Product Code CAZ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 02/21/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/21/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2018
Device Model NumberSJ-05501
Device Lot Number23F16K02763001128
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 02/21/2017 Patient Sequence Number: 1
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