Catalog Number 383557 |
Device Problem
Leak/Splash (1354)
|
Patient Problem
Extravasation (1842)
|
Event Date 07/16/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
|
|
Event Description
|
It has been reported that one bd nexiva closed iv catheter system ¿ single port with maxzero¿ needleless connector 20 ga 1.25 in (1.1 x 32 mm) has been found with the needle through the catheter during use.The following has been provided by the initial reporter: it was reported that the wire went through the plastic catheter tip and the iv blew.Per email: when the nurse was attempting to start and iv, when threading the catheter the wire went through the plastic catheter tip and the iv blew.Bd nexiva closed iv catheter system single port with maxzero needleless connector.
|
|
Manufacturer Narrative
|
Investigation summary: a device history review was conducted for lot number 8025512.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.A sample could not be obtained for evaluation and testing.Without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.
|
|
Event Description
|
It has been reported that one bd nexiva closed iv catheter system ¿ single port with maxzero¿ needleless connector 20 ga 1.25 in (1.1 x 32 mm) has been found with the needle through the catheter during use.The following has been provided by the initial reporter: it was reported that the wire went through the plastic catheter tip and the iv blew.Per email: when the nurse was attempting to start and iv, when threading the catheter the wire went through the plactic catheter tip and the iv blew.Bd nexiva closed iv catheter system single port with maxzero needleless connector.
|
|
Search Alerts/Recalls
|