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

Model Number 381834

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 08/10/2022

Event Type  Injury  

Manufacturer Narrative

Date of event is unknown; awareness date has been used for this field.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 was reported while using bd insyte¿ autoguard¿ shielded iv catheter an allergic reaction required antibiotics and lab testing.There was no report of patient impact.The following information was provided by the initial reporter: verbatim: i recently spent time in hospital and had to have iv needles.I reacted three times at site of where needle was.Have you ever had any one react to plastic in needle before? the first iv was put in the ambulance.Two days after i woke up with a lot pain in arm and having trouble to move it.The area about 4 inches by six inches very red.The vein was about size pencil in diameter and hard.I had to take antibiotics and hot and cold compresses.They removed it and put another one below it.Two days later it started to get very red as well.Then several days later when i was at a different hospital another iv was started in opposite arm.Two days and it started to turn red.This leads me to think that there is something in the product that i am allergic to.The doctor sent the 2nd one to lab to culture it.Nothing showed in the specimen.

Manufacturer Narrative

H.6.Investigation summary: the photo provided for this incident did not present sufficient evidence to identify or confirm the alleged failure or to establish a definite root cause.Since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.Examination of the actual product involved may provide clarification as to the cause for the reported failure.A device history record review showed no non-conformances associated with this issue during the production of this batch.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported while using bd insyte¿ autoguard¿ shielded iv catheter an allergic reaction required antibiotics and lab testing.There was no report of patient impact.The following information was provided by the initial reporter: verbatim: i recently spent time in hospital and had to have iv needles.I reacted three times at site of where needle was.Have you ever had any one react to plastic in needle before? the first iv was put in in the ambulance.Two days after i woke up with a lot pain in arm and having trouble to move it.The area about 4 inches by six inches very red.The vein was about size pencil in diameter and hard.I had to take antibiotics and hot and cold compresses.They removed it and put another one below it.Two days later it started to get very red as well.Then several days later when i was at a different hospital another iv was started in opposite arm.Two days and it started to turn red.This leads me to think that there is something in the product that i am allergic to.The doctor sent the 2nd one to lab to culture it.Nothing showed in the specimen.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
• Type of Device: INTRAVASCUALR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15351158
• MDR Text Key: 299270247
• Report Number: 1710034-2022-00470
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903818341
• UDI-Public: 00382903818341
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K201075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/05/2022

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?: No
• Device Operator: Other
• Device Expiration Date: 08/31/2024
• Device Model Number: 381834
• Device Catalogue Number: 381834
• Device Lot Number: 1264046
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/10/2022
• Initial Date FDA Received: 09/02/2022
• Supplement Dates Manufacturer Received: 10/05/2022
• Supplement Dates FDA Received: 10/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention