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

Catalog Number 381411

Device Problem Defective Component (2292)

Patient Problems Hypoglycemia (1912); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/20/2023

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: from related record: reported issue per customer: hospital nursery is having issues with the product.They seem lighter and they are difficult to insert.They did not have problems with the previous ones.17oct2023: 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.24oct2023: 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? we had to start an umbilical line in order to manage care.03nov2023: on (b)(6) 23 we had to start an umbilical line bc we were not able to establish peripheral iv access.

Manufacturer Narrative

Additional information received indicating that the customer was not able to access the patient with a pivc and utilized an alternative method for treatment.The pt.Weight can be found in narrative in b.Not appropriate to round to whole numbers.

Event Description

Additional information received: on 17nov2023: it was stated that we had to start an umbilical line in order to manage care.What type of care did the patient require? umbilical venous catheter for management of hypoglycemia.Can you provide any patient information (age, dob, weight, underlying condition/diagnosis that required treatment)? on date of birth: (b)(6) 2023, 3560gm, newborn hypoglycemia.

Manufacturer Narrative

Investigation results: since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.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.

Event Description

No additional information.

• Brand Name: BD INSYTE-N AUTOGUARD
• Type of Device: PERIPHERAL IV CATHETERS
• 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: 18088323
• MDR Text Key: 327588871
• Report Number: 1710034-2023-01265
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903814114
• UDI-Public: (01)00382903814114
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 02/12/2024

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: 10/17/2023
• Initial Date FDA Received: 11/07/2023
• Supplement Dates Manufacturer Received: 11/17/2023; 02/12/2024
• Supplement Dates FDA Received: 12/08/2023; 02/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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