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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX INC. / ARROW INTERNATIONAL, INC. ARROW FLEX TIP PLUS EPIDURAL KIT

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TELEFLEX INC. / ARROW INTERNATIONAL, INC. ARROW FLEX TIP PLUS EPIDURAL KIT Back to Search Results
Device Problem Material Split, Cut or Torn (4008)
Patient Problem Stenosis (2263)
Event Date 08/30/1988
Event Type  Injury  
Event Description
Epidural needle slightly bent after catheter placement. When catheter was discontinued, the tip was not intact and there was a hairline split at the catheter end. Ct on (b)(6) 2018 also revealed that pt had "advanced l5-s1 degenerative disc disease with chronic small right paracentral disc protrusion resulting in mid right canal stenosis and mild right lateral recess narrowing. ".
 
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Brand NameARROW
Type of DeviceFLEX TIP PLUS EPIDURAL KIT
Manufacturer (Section D)
TELEFLEX INC. / ARROW INTERNATIONAL, INC.
MDR Report Key7872565
MDR Text Key120335681
Report NumberMW5079773
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 09/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/12/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
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: 09/12/2018 Patient Sequence Number: 1
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