MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 18G X 1.16IN (1.3 X 30 MM) INSYTE AUTOGUARD; INTERVASCULAR CATHETER

Catalog Number 381444

Device Problems Delivered as Unsterile Product (1421); Material Protrusion/Extrusion (2979)

Patient Problems Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)

Event Date 09/14/2019

Event Type  Injury  

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 18g x 1.16in (1.3 x 30 mm) insyte autoguard has been found with the needle through the shield after use.The following has been provided by the initial reporter: it was reported that the previously retracted (now contaminated) needle to project out of the protected casing and stick the rn.I wanted to make you aware of an incident that occurred in our ed while an ed rn placed an iv on a patient using the equipment above.When the task was completed she gathered both the vacutainer and the insyte autoguard to discard.The needle on the autoguard retracted as it should.There is a hole at the tip of the autoguard.The blunt end of the vacutainer connected with the hole at the tip of the autoguard.This 'contact' caused the previously retracted (now contaminated) needle to project out of the protected casing and stick the rn.

Manufacturer Narrative

Investigation summary: received one iag 18ga unit inside a sealed package from lot 9156977.A smiths saf-t holder within a sealed package was also received.A review of the device history record revealed no irregularities during the manufacture of the reported lot.Visual examination: no physical-mechanical damage was observed on any of the components of the representative unit received.Functional: the white button was then pressed, and the needle successfully retracted without resistance.According to the event description ¿the needle on the autoguard retracted as it should¿ then ¿the blunt end of the vacutainer connected with the hole at the tip of the autoguard¿ ¿ reproduction of the incident was performed ¿ see picture below ¿ this action is not the intended usage of the product.Per ifu: contraindication.Conclusion(s): customer related ¿ the needle was pushed to the out position by the way the clinician was handling the unit along with the sat-t holder.The barrel is not intended to have any devices introduced through its back end.

Event Description

It has been reported that one 18g x 1.16in (1.3 x 30 mm) insyte autoguard has been experiencing inability for the needle to retract after use.The following has been provided by the initial reporter: it was reported that the previously retracted (now contaminated) needle to project out of the protected casing and stick the rn.I wanted to make you aware of an incident that occurred in our ed while an ed rn placed an iv on a patient using the equipment above.When the task was completed she gathered both the vacutainer and the insyte autoguard to discard.The needle on the autoguard retracted as it should.There is a hole at the tip of the autoguard.The blunt end of the vacutainer connected with the hole at the tip of the autoguard.This 'contact' caused the previously retracted (now contaminated) needle to project out of the protected casing and stick the rn.

Manufacturer Narrative

Correction: updated rationale the following information has been updated: describe event or problem: it has been reported that one 18g x 1.16in (1.3 x 30 mm) insyte autoguard has been experiencing inability for the needle to retract after use.The following has been provided by the initial reporter: it was reported that the previously retracted (now contaminated) needle to project out of the protected casing and stick the rn.I wanted to make you aware of an incident that occurred in our ed while an ed rn placed an iv on a patient using the equipment above.When the task was completed she gathered both the vacutainer and the insyte autoguard to discard.The needle on the autoguard retracted as it should.There is a hole at the tip of the autoguard.The blunt end of the vacutainer connected with the hole at the tip of the autoguard.This 'contact' caused the previously retracted (now contaminated) needle to project out of the protected casing and stick the rn.Device codes: 2979.

Event Description

It has been reported that one 18g x 1.16in (1.3 x 30 mm) insyte autoguard has been experiencing inability for the needle to retract after use.The following has been provided by the initial reporter: it was reported that the previously retracted (now contaminated) needle to project out of the protected casing and stick the rn.I wanted to make you aware of an incident that occurred in our ed while an ed rn placed an iv on a patient using the equipment above.When the task was completed she gathered both the vacutainer and the insyte autoguard to discard.The needle on the autoguard retracted as it should.There is a hole at the tip of the autoguard.The blunt end of the vacutainer connected with the hole at the tip of the autoguard.This 'contact' caused the previously retracted (now contaminated) needle to project out of the protected casing and stick the rn.

• Brand Name: 18G X 1.16IN (1.3 X 30 MM) INSYTE AUTOGUARD
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 9141822
• MDR Text Key: 166948680
• Report Number: 1710034-2019-01070
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903814443
• UDI-Public: 30382903814443
• Combination Product (y/n): N
• PMA/PMN Number: K952861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup,Followup
• Report Date: 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: 381444
• Device Lot Number: 9156977
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other