MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD INSYTE-N¿ AUTOGUARD¿ SHIELDED IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number 38182314

Device Problem Defective Component (2292)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/19/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that bd insyte-n¿ autoguard¿ shielded iv catheter had safety failure during use.

Manufacturer Narrative

Investigation: bd was able to verify the reported issue of needle retraction failure.The received sample needle was partially retracted.The possible cause for the problem was verified during the plug placement step, where the rod, which is inserted into the inside of the grip, could collide with the plug, causing a damage on this component.This damage prevents the movement of the button during its activation, thus preventing retraction of the cannula.Although there was already an established alignment method to avoid this problem during the process, there was no sensor that would ensure that the part would be discarded if the rod hit the grip.The change of the rod sensor program was performed, so that in case of a contact of the rod with the grip the part is discarded.Dhr review: a review of the device history record was completed for sub-assembly #8607679 lot 8057538 manufactured from 02-mar-18 to 29-mar-18 used in claimed lot 8086910.The batch was analyzed for "needle retraction" and ¿part activation¿ tests, and it was not evidenced record of failure of activation of the part during the analysis of these lots.

Event Description

It was reported that bd insyte-n¿ autoguard¿ shielded iv catheter had safety failure during use.

• Brand Name: BD INSYTE-N¿ AUTOGUARD¿ SHIELDED IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora
• MDR Report Key: 8232137
• MDR Text Key: 132588538
• Report Number: 9610048-2018-00224
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903818235
• UDI-Public: 00382903818235
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 03/21/2019

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?: Yes
• Device Operator: Other
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 38182314
• Device Lot Number: 8086910
• Initial Date Manufacturer Received: 12/19/2018
• Initial Date FDA Received: 01/09/2019
• Supplement Dates Manufacturer Received: 12/19/2018
• Supplement Dates FDA Received: 03/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other