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

Catalog Number	381034
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3.The date received by manufacturer has been used for this field.H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
It was reported that bd iag bc pro global needle retracted prematurely.The following information was provided by the initial reporter: needle retacted before iv through patients skin, white retractor button definitely not pressed.No adverse event reported.
Additional Manufacturer Narrative
The complaint of premature needle retraction was confirmed based on the circumstantial evidence of the returned sample.One 20g insyte autoguard was provided for investigation.The needle was received fully retracted within the safety shield and the iv catheter was received without the needle cover.No damage or defects associated with the manufacturing process were identified on the returned sample.A review of the inspection records and quality/manufacturing controls for the implicated lot indicated no related issues with the manufacturing process.Manufacturing controls are in place to mitigate the occurrence of this type of failure.The complaint has been documented and will continue to be monitored as part of ongoing efforts to identify potential manufacturing related issues.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.
Event or Problem Description
No additional information.

• Brand Name: BD 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: 22045625
• Report Number: 1710034-2025-00853
• Device Sequence Number: 8908173
• Product Code: FOZ
• UDI-Device Identifier: 00382903810345
• UDI-Public: (01)00382903810345(11)241127(17)271031(10)4331566
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2025

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: 381034
• Device Lot Number: 4331566
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2025
• Supplement Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 05/19/2025
• Supplement Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown