MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number 381834

Device Problems Retraction Problem (1536); Defective Device (2588)

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

Event Date 02/21/2019

Event Type  malfunction  

Manufacturer Narrative

(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 the safety mechanism on the bd insyte¿ autoguard¿ shielded iv catheter wasn't working and caused a delay in needle retraction during use.The customer reported 632 occurrences of this event.As reported by the customer, "the safety machanism can't work well.Compared with other or previous batch, the timing of needle retracted into the cavity is delayed.This may cause needle stick injury.".

Manufacturer Narrative

H.6.Investigation: review of dhr revealed all required challenge samples, set-up and in process testing was performed in accordance with the quality plans.Review disclosed no reject activity findings throughout the build of this lot that would impact the outcome of the quality of the product relevant to the defect.Received 630 unused iag 20ga units in sealed packages from catalog number 381834, lot number 8151905.(b)(4) unused loosed in a plastic bag, (b)(4) dispensers with (b)(4) units each, one dispenser with (b)(4) units.Pulled a random sample of 76 and performed the following: visual/microscopic evaluation: observed there was no mechanical/physical damage to any of the components (spring, needle, needle hub, grips) or evidence of adhesive on the button or hub.Functional test (needle retraction) was performed: performed the hub twist test then depressed the buttons.The retractions were successful, no delayed reaction was observed.The defect needle retraction slow was not identified, replicated or confirmed with the returned units.The returned units did not display any adverse characteristics that would contribute to the defect the customer experienced.

Event Description

It was reported that the safety mechanism on the bd insyte¿ autoguard¿ shielded iv catheter wasn't working and caused a delay in needle retraction during use.The customer reported 632 occurrences of this event.As reported by the customer, "the safety mechanism can't work well.Compared with other or previous batch, the timing of needle retracted into the cavity is delayed.This may cause needle stick injury.".

• Brand Name: BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 8404817
• MDR Text Key: 138509930
• Report Number: 1710034-2019-00278
• Device Sequence Number: 0
• Product Code: FOZ
• PMA/PMN Number: K952861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 05/10/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: 381834
• Device Lot Number: 8151905
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other