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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD SAFETY SELDINGER INTRODUCER; NEEDLE
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BARD SAFETY SELDINGER INTRODUCER; NEEDLE Back to Search Results
Model Number 1174108D
Device Problems Defective Device (2588); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/17/2015
Event Type  malfunction  
Event Description
In bard power picc kits, some of the "safety seldinger introducer" needles have had the safety feature not work.After using the needle, when the nurse slides the hub of the needle down to the needle tip (which is supposed to be covered with a metallic safety piece as a result.In some cases the safety clip has not worked, but has remained near the catheter hub as the nurse slid her fingers down to the tip to "cover" it with the safety clip.This can potentially cause the nurse to accidently stick herself with a bloody needle.Since (b)(6) 2014, i have found defective needles in kits: (b)(4) (lot revj1276), (b)(4) (lot revj1271 and revj1715) and (b)(4) (lot revj1836).Dates of use: (b)(6) 2014 to currently.Diagnosis or reason for use: picc (peripherally inserted central cath) insertion.
 
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Brand Name
SAFETY SELDINGER INTRODUCER
Type of Device
NEEDLE
Manufacturer (Section D)
BARD
sale lake city UT 84116
MDR Report Key4546532
MDR Text Key5511423
Report NumberMW5040906
Device Sequence Number1
Product Code DYB
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 02/19/2015
3 Devices were Involved in the Event: 1   2   3  
1 Patient was Involved in the Event
Date FDA Received02/19/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/31/2016
Device Model Number1174108D
Device Lot NumberREYJ1271
Was Device Available for Evaluation? No
Date Returned to Manufacturer01/19/2015
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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