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

Catalog Number	381012
Medical Device Problem Codes	Defective Component (2292); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Specifically, there is no sharpness, and it could not penetrate the skin (epidermis) (did not reach the blood vessel).When a new one was opened and punctured again, it could be punctured as usual without any problem.
Additional Manufacturer Narrative
This mdr is the result of an investigation finding.Device eval: our quality engineer inspected the sample and photographs submitted for evaluation.Your report of resistance when puncturing was confirmed from the circumstantial evidence was observed on the device in the provided photographs.The cause appeared to be manufacturing related.Five photographs and one 24g insyte autoguard device from lot 5045778 were provided for investigation.The shape of the bevel at the catheter tip appeared to be incorrect in the photographs, which would likely create complications during insertion.A functional test to simulate needle tip and catheter tip penetration revealed that the penetration force of the returned needle and catheter were within specification.The returned sample appeared to be different than the sample in the photographs.The bevel shape of the catheter tip appeared to be a contributing factor of the reported issue.The appropriate personnel have been notified and we appreciate you taking the time to bring this observation to our attention.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.
Additional Manufacturer Narrative
A code updated.
Event or Problem Description
No new information.

• Brand Name: INSYTE AUTOG BC GLOBAL
• Common Device Name: 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: 23064618
• Report Number: 1710034-2025-01517
• Device Sequence Number: 21343132
• Product Code: FOZ
• UDI-Device Identifier: 00382903810123
• UDI-Public: (01)00382903810123
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: 381012
• Device Lot Number: 5045778
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2025
• Supplement Date Received by Manufacturer: 09/16/2025
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 10/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown