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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL PRESSURE INJECTABLE MULTI-LUMEN CVC KIT WITH BLUE FLEXTIP CATHETER

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ARROW INTERNATIONAL PRESSURE INJECTABLE MULTI-LUMEN CVC KIT WITH BLUE FLEXTIP CATHETER Back to Search Results
Lot Number 13F19G0661
Device Problem Material Twisted/Bent (2981)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/29/2019
Event Type  malfunction  
Event Description
Central venous line placement - 1st wire unable to pass dilator over due to kink in wire. 2nd wire unable to advance wire through needle due to multiple bends in wire. Pressure injectable multi-lumen cvc kit with blue flextip catheter arrow international, lot: 13f19g0661, use by: 2021-02-28, (b)(4).
 
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Type of DevicePRESSURE INJECTABLE MULTI-LUMEN CVC KIT WITH BLUE FLEXTIP CATHETER
Manufacturer (Section D)
ARROW INTERNATIONAL
po box 12600
durham NC 27709
MDR Report Key9495347
MDR Text Key172023014
Report Number9495347
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/03/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/19/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number13F19G0661
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/03/2019
Event Location No Information
Date Report to Manufacturer12/19/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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