MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. IAG BC PRO GLOBAL WING; PERIPHERAL IV CATHETERS

Catalog Number	382923
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	09/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Prick with contaminated needle after ktr insertion in a patient.Material defect, the needle was not completely retracted and when it was thrown away the needle went back into the thumb.9/5/2025 customer response: has the patient or user suffered harm? if yes, please explain yes, aes for care staff.Did the malfunction cause a needlestick injury to healthcare staff or the patient? yes, care staff.Were healthcare personnel exposed to blood or body fluids? yes.Was there a problem with the safety device? yes.Were other measures taken? follow-up of internal procedure in the event of an aes.Response on 12-sep-2025.Here is the department's response: "the staff member concerned went to a&e to report the incident and complete the various paperwork.A blood sample was taken from the patient and the agent himself.I'm not aware of the results.But follow-up is underway.".
Additional Manufacturer Narrative
H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Additional Manufacturer Narrative
Our quality engineer inspected the sample submitted for evaluation.Your report that the needle was not fully retracted was confirmed and the cause appeared to be manufacturing related.One insyte autoguard needle was returned for investigation.A microscopic examination revealed an impression in the barrel along the fractured edge.The barrel component was likely crushed during assembly due to misalignment.This prevented the needle from fully retracting.The needle tip remained exposed.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 we appreciate you taking the time to bring this observation to our attention.
Event or Problem Description
No new information.

• Brand Name: IAG BC PRO GLOBAL WING
• 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: 23064968
• Report Number: 1710034-2025-01518
• Device Sequence Number: 18562068
• Product Code: FOZ
• UDI-Device Identifier: 00382903829231
• UDI-Public: (01)00382903829231
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2025

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: 382923
• Device Lot Number: 5105139
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2025
• Supplement Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/16/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown