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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW EPIDURAL KIT FLEX TIP PLUS CATHETER

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ARROW EPIDURAL KIT FLEX TIP PLUS CATHETER Back to Search Results
Model Number HS--05501
Device Problem Fracture (1260)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/27/2017
Event Type  Injury  
Event Description
Arrow epidural catheterization kit with flextip plus catheter product no. Hs-05501 fractured when removing the catheter from the patient. This occurred with 3 patients. Lot number 23f17-a0560 was removed from clinical area as well as all other lot numbers until issue is resolved. Patient received epidural catheters for total joint replacement, (b)(6) 2017.
 
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Brand NameEPIDURAL KIT
Type of DeviceFLEX TIP PLUS CATHETER
Manufacturer (Section D)
ARROW
louisv ille KY 40241
MDR Report Key6442316
MDR Text Key71267354
Report NumberMW5068720
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 03/27/2017
3 Devices were Involved in the Event: 1   2   3  
1 Patient was Involved in the Event
Date FDA Received03/27/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2018
Device Model NumberHS--05501
Device Lot Number23F17A0560
Was Device Available for Evaluation? Yes
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: 03/27/2017 Patient Sequence Number: 1
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