MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD INSYTE AUTOGUARD; CATHETER

Catalog Number UNKNOWN

Device Problems Delivered as Unsterile Product (1421); Retraction Problem (1536)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/06/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that unspecified bd¿ insyte autoguard had needle retraction issues.The following information was provided by the initial reporter: material no: unknown, batch no: unknown.It was reported that nurses had difficulty using bd insyte autoguard-has increased frequency of failed iv pokes.Verbatim: nurses had difficulty using product.Has increased frequency of failed iv pokes.This is an ongoing issue that several nurses reported simultaneously about the new bd insyte autoguard iv needles.They have previously been using a braun device.Difficult to pierce vessel wall.When pressing button to deploy device, the safety catch shoots away and lands across room.Catheter falls off needle.If nurse forgets to break seal on catheter by rotating 360 degrees prior to use, the seal is extremely difficult to break while needle is in patient and can lead to missing the vein.Indicated that handle is bulky and has increases the number of misses when trying to poke vein (nurse indicates she as missed 3-4 times in a row even with ultrasound guidance, where before they never missed).

Manufacturer Narrative

H.6.Investigation: bd was not able to duplicate or confirm the customer¿s indicated failure as no sample, batch, or lot code was provided.Dhr could not be performed due to unknown lot#.Root cause could not be determined.H3 other text : see h.10.

Event Description

It was reported that unspecified bd¿ insyte autoguard had needle retraction issues.The following information was provided by the initial reporter: material no: unknown batch no: unknown.It was reported that nurses had difficulty using bd insyte autoguard-has increased frequency of failed iv pokes.Verbatim: nurses had difficulty using product.Has increased frequency of failed iv pokes.This is an ongoing issue that several nurses reported simultaneously about the new bd insyte autoguard iv needles.They have previously been using a braun device.Difficult to pierce vessel wall.When pressing button to deploy device, the safety catch shoots away and lands across room.Catheter falls off needle.If nurse forgets to break seal on catheter by rotating 360 degrees prior to use, the seal is extremely difficult to break while needle is in patient and can lead to missing the vein- indicated that handle is bulky and has increases the number of misses when trying to poke vein (nurse indicates she as missed 3-4 times in a row even with ultrasound guidance, where before they never missed).

• Brand Name: UNSPECIFIED BD INSYTE AUTOGUARD
• Type of Device: CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11599782
• MDR Text Key: 268787890
• Report Number: 2243072-2021-00912
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 05/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1