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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL, INC. FLEXTIP PLUS; ANESTHESIA CONDUCTION KIT

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ARROW INTERNATIONAL, INC. FLEXTIP PLUS; ANESTHESIA CONDUCTION KIT Back to Search Results
Device Problem Failure to Advance (2524)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/08/2015
Event Type  malfunction  
Event Description
During insertion of epidurals, the epidural space was identified with loss of resistance technique using normal saline; the obturator was removed, however, we were then unable to pass arrow catheter into the epidural space.A different catheter not in the kit is used and passes without difficulty.This has happened multiple times to a variety of anesthetists and physicians over the last 3-4 months.They feel the separate catheter has more flexibility than the catheter contained in the kit.No patient harm during any of the insertions; working with the vendor.Manufacturer response for epidural catheter kit, arrow epidural catheter kit (per site reporter): vendor working with us, gave us other catheters to use; took our info and experience back to their research and development team.
 
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Brand Name
FLEXTIP PLUS
Type of Device
ANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
ARROW INTERNATIONAL, INC.
2400 bernville road
reading PA 19605
MDR Report Key5027481
MDR Text Key23947220
Report Number5027481
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 User Facility
Reporter Occupation Other
Report Date 07/07/2015
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 Physician
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/07/2015
Event Location Hospital
Date Report to Manufacturer07/07/2015
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/25/2015
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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