MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE-N AUTOGUARD; PERIPHERAL IV CATHETER

Catalog Number 381411

Device Problems Defective Component (2292); Dull, Blunt (2407); Failure to Advance (2524)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/05/2023

Event Type  Injury  

Manufacturer Narrative

H.3.A device evaluation and/or device history review is anticipated but is not complete.If additional information becomes available, a supplemental report will be filed.

Event Description

It was reported that bd insyte-n autoguard are difficult to insert.The following information was provided by the initial reporter: verbatim: reported issue per customer: hospital nursery is have issues with the product.They seem lighter and they are difficult to insert.They did not have problems with the previous ones.(b)(6) 2023.- date of event: (b)(6) 2023.- how many occurrences of defective set(s) affected? i am not sure what this question is asking.Several attempts were made with bd insyte autoguard iv catheter lot number 3114869.- any adverse events or serious injury reported to patient or healthcare professional? no.- what was the patient outcome? multiple iv attempts on newborn patient, unable to start iv access.- was there any delay of, or change in, the course of treatment due to this event? yes.- what procedure was being performed? iv access.- what medication was used in the procedure? n/a.(b)(6) 2023.¿ is it an issue with the sharpness of the needle? yes.¿ is it an issue with the ability to thread the catheter? if able to pierce, not thread catheter.¿ in your opinion, how does the reported 'they seem lighter' impact the ability to use the device? the needle doesn¿t seem thick enough.¿ for this question, ¿was there any delay of, or change in, the course of treatment due to this event? yes¿, the answer you provided was ¿yes¿.May i know was there any change of the treatment or it was just a delay in treatment? for one patient we were unable to manage blood sugars with iv dextrose.

Manufacturer Narrative

Updated information received indicating that piv loss occurred before the decline in medical condition and that an alternative treatment plan was enacted when the patient became hypoglycemic.There is no information indicating that the hcp team attempted and failed additional pivc placement attempts with the hypoglycemia diagnosis.

Event Description

Additional information received: 17nov2023.It was stated that 'we were unable to control blood sugar with iv.How was the blood sugar controlled (what treatment replaced iv intervention)? gavage feeding with shorter intervals between feeds.Was the infant hypoglycemic? not at the time of loss of access.Can you provide any patient information (age, dob, weight, underlying.Condition/diagnosis that required treatment)? 4 day old, (b)(6) 2023, newborn delivered at 32 weeks 3 days, 1691gm.

Manufacturer Narrative

Investigation results: our quality engineer inspected the representative samples submitted for evaluation.Bd received 114 sealed 24ga x 0.56in.Insyte-n autoguard units from lot number 3114869.A penetration and drag test was performed on all units.All units passed catheter tip and drag force specifications therefore threading difficulty was not confirmed.One unit failed for needle tip specifications.The failed unit was then microscopically analyzed.It was confirmed that the needle tip was found unacceptable.The outer diameter of this unit was tested and found to be within specifications.Regarding the dull/blunt needle, this was determined to be manufacturing related due to a machine misalignment or while the grip is being inserter into the needle cover.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.

Event Description

No additional information.

• Brand Name: BD INSYTE-N AUTOGUARD
• Type of Device: PERIPHERAL IV 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18088320
• MDR Text Key: 327587854
• Report Number: 1710034-2023-01264
• 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: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/26/2023

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: Health Professional
• Device Catalogue Number: 381411
• Device Lot Number: 3114869
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/24/2023
• Initial Date FDA Received: 11/07/2023
• Supplement Dates Manufacturer Received: 11/17/2023; 12/26/2023
• Supplement Dates FDA Received: 12/08/2023; 01/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 4 DA