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

Catalog Number	382923
Medical Device Problem Codes	Retraction Problem (1536); Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	Ecchymosis (1818)
Date of Event	09/30/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
The nurse was unable to assemble the catheter and found it impossible to retract the needle after the puncture.The device was removed from the patient's arm as it was.No major trauma was observed, only a slight bruise at the puncture site.Date of event unknown.
Additional Manufacturer Narrative
Our quality engineer inspected the photographs submitted for evaluation.Your report of a damaged catheter was confirmed; however, the root cause could not be determined from the photographs.The photos showed a 22g insyte autoguard bc device with evidence of use.The needle was protruding through the catheter tubing near the tip, which may have affected the reported inability to retract the needle.This type of damage can occur from reinserting the needle into the catheter during the placement procedure.Without the physical sample, the root cause of the reported event could not be determined.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.
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: 23330489
• Report Number: 1710034-2025-01630
• Device Sequence Number: 15937173
• Product Code: FOZ
• UDI-Device Identifier: 00382903829231
• UDI-Public: (01)00382903829231
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 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: 382923
• Device Lot Number: 4331571
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2025
• Supplement Date Received by Manufacturer: 10/31/2025
• Initial Report FDA Received Date: 10/17/2025
• Supplement Report FDA Received Date: 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/06/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown