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

Catalog Number 381511

Device Problem Unsealed Device Packaging (1444)

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

Event Date 06/17/2023

Event Type  malfunction  

Manufacturer Narrative

E1.Address information was not able to be obtained, therefore, nj was used as a place holder.H3.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 3 of the bd insyte¿ autoguard¿ iv catheter were open not seal properly.The following information was provided by the initial reporter: insyte-n autoguard winged iv catheter packaging sleeve on singular iv was open and not sealed on top properly.About three ivs have this problem.

Event Description

It was reported that 3 of the bd insyte¿ autoguard¿ iv catheter were open not seal properly.The following information was provided by the initial reporter: insyte-n autoguard winged iv catheter packaging sleeve on singular iv was open and not sealed on top properly.About three ivs have this problem.

Manufacturer Narrative

The following fields have been updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 11-jul-2023.H.6.Investigation summary: our quality engineer inspected the samples submitted for evaluation.Bd received 3 24g x 0.56in insyte-n autoguard devices from lot number 3066132.A gross visual inspection shows 3 units in the packaging and the packaging near the needle cover has an opening exposing the units on all three devices.Upon investigation, your reported issue was confirmed, and the likely root cause of the sterility breach observed on these units is manufacturing related.Breach in packaging may occur due to wrong advancement or a misaligned cutter when cross cutting the package.To mitigate the occurrence of this type of defect, quality control plans, sampling and machine set up have been established.A device history record review showed no non-conformances associated with this issue during the production of this batch.The appropriate personnel have been notified.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.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ IV CATHETER
• Type of Device: INTRAVASCULAR 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17313412
• MDR Text Key: 319488702
• Report Number: 1710034-2023-00790
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 381511
• Device Lot Number: 3066132
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/20/2023
• Initial Date FDA Received: 07/12/2023
• Supplement Dates Manufacturer Received: 08/08/2023
• Supplement Dates FDA Received: 08/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1