MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE AUTOG BC; PERIPHERAL IV CATHETERS

Catalog Number 382523

Device Problem Defective Component (2292)

Patient Problem Hypoglycemia (1912)

Event Date 10/26/2023

Event Type  Injury  

Manufacturer Narrative

Our quality engineer inspected the sample submitted for evaluation.Bd received one unsealed 22gx1.00in insyte autoguard device.A gross visual inspection shows that the unit has been used.The needle cover was incorrectly replaced over the grip and the needle was received retracted in the barrel.Microscopic inspection of the catheter revealed the catheter tip to have some inconsistencies.There was flash present, and the flow lines were distorted.Your reported issue was confirmed as the catheter tip was found unacceptable.This was physical/mechanical evidence to confirm and support a manufacturing process related issue for the reported defect.The flash may have formed, and flow lines may get distorted due to lube temperature being too low during tipping or if there is insufficient lube due to die /coil misalignment.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 and complaints received for this device and reported condition will continue to be tracked and trended.

Event Description

It was reported that bd insyte autog bc catheter difficult to thread.The following information was provided by the initial reporter: multiple attempts fir iv access x 3rns before successfully access.There was delay to patient care.Baby having critical low blood sugar levels despite oral treatment ¿ iv treatment delayed due to inability to access an iv.Third iv changed to 20g buckled skin with threading.Response received on 02-nov-2023.I apologize ¿ in the report the department manager had stated the 20g but in reality the iv¿s are 22g x it wasn¿t until i got these devices that i notice the mistake.

• Brand Name: BD INSYTE AUTOG BC
• 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: 18394185
• MDR Text Key: 331333413
• Report Number: 1710034-2023-01476
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110443
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• 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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 382523
• Device Lot Number: 1214219
• Initial Date Manufacturer Received: 12/20/2023
• Initial Date FDA Received: 12/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other