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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL, INC. FLEX TIP PLUS EPIDURAL CATHETERIZATION KIT; EPIDURAL CATHETER/ANESTHESIA CONDUCTION KIT

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ARROW INTERNATIONAL, INC. FLEX TIP PLUS EPIDURAL CATHETERIZATION KIT; EPIDURAL CATHETER/ANESTHESIA CONDUCTION KIT Back to Search Results
Model Number 19 GAUGE
Device Problem Break (1069)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 02/16/2019
Event Type  Injury  
Event Description
When the rn was removing the epidural catheter, it was noted that the catheter tip was not intact.The patient was taken to the operating room for removal of the tip on (b)(6) 2018.
 
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Brand Name
FLEX TIP PLUS EPIDURAL CATHETERIZATION KIT
Type of Device
EPIDURAL CATHETER/ANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
ARROW INTERNATIONAL, INC.
MDR Report Key8386026
MDR Text Key137732300
Report NumberMW5084571
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 Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 02/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date10/31/2020
Device Model Number19 GAUGE
Device Catalogue NumberAK-05502
Device Lot Number23F18M0381
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/21/2019
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/01/2019
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age36 YR
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