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

Catalog Number	382944
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Every time iv is inserted into a patient and the needle retraction button is press, it won't retract.This causes difficulty trying to keep the iv patent while removing the needle and most times the iv will not stay in the vein as a result.End users uses sometimes 2 or 3 and even 4 ivs to get one to retract and the iv stay in patient.
Additional Manufacturer Narrative
B3: the date received by manufacturer has been used for this field.H3: 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 photograph submitted for evaluation.Your report that the needle failed to retract or was slow to retract could not be confirmed from the photograph that was provided for investigation.The photo showed the unit package of a 24g insyte autoguard.The reported issue was not demonstrated in the photo.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.Examination of the actual product involved may provide clarification as to the cause for the reported failure.A device history record review showed no non-conformances associated with this issue during the production of this batch.

• 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: 22969601
• Report Number: 1710034-2025-01456
• Device Sequence Number: 9007474
• Product Code: FOZ
• UDI-Device Identifier: 00382903829446
• UDI-Public: (01)00382903829446
• 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,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2025

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: 382944
• Device Lot Number: 4298108
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2025
• Supplement Date Received by Manufacturer: 10/31/2025
• Initial Report FDA Received Date: 09/04/2025
• Supplement Report FDA Received Date: 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/05/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown