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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. PORT ACCESS NEEDLE; SET, ADMINISTRATION, INTRAVASCULAR
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BARD ACCESS SYSTEMS, INC. PORT ACCESS NEEDLE; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 0672034
Device Problem Retraction Problem (1536)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/24/2017
Event Type  malfunction  
Event Description
A patient port was accessed with a 20-gauge power needle.The safety device engaged when the needle was removed.At the time of disposal rn started to feel pin prick on finger, upon examination of device noticed the safety mechanism never fully engaged, despite hearing the click which confirms safety mechanism is latched.This event was repeated when another needle from the same lot was used on a different patient.There was no harm to either the patient or nurse.
 
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Brand Name
PORT ACCESS NEEDLE
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BARD ACCESS SYSTEMS, INC.
605 north 5600 west
salt lake city UT 84116
MDR Report Key6348849
MDR Text Key67944531
Report Number6348849
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 01/26/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Nurse
Device Expiration Date02/28/2020
Device Model Number0672034
Device Catalogue Number0672034
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/26/2017
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer01/26/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
CHEMOTHERAPY
Patient Age65 YR
Patient Weight99
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