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

Catalog Number	381044
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is the result of an investigation finding: device evaluation: our quality engineer inspected the samples submitted for evaluation.Bd received 13 18ga x 1.16in.Insyte autoguard bc units from lot number 5037132.A gross visual inspection shows that 12 devices are sealed in their packaging and do not appear to have physical damage.The 13th unit showed signs of usage.The used unit was unable to be fully tested as the needle had been retracted in the barrel.The report that the needle was getting caught in the catheter during retraction was confirmed and the cause appeared to be manufacturing related.A functional test of the sealed 18g insyte autoguard bc devices that were returned for investigation revealed that the safety mechanism worked as designed; however, it appeared that the notch in the needle caught on the blood control valve during retraction.The dimensions of the needle notch were within specification.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.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.
Event or Problem Description
A malfunction of the catheter safety system was observed.When the button for removing the canula was pressed, the canula became stuck in the catheter.

• Brand Name: IAG BC PRO 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: 23316753
• Report Number: 1710034-2025-01624
• Device Sequence Number: 5802385
• Product Code: FOZ
• UDI-Device Identifier: 00382903810444
• UDI-Public: (01)00382903810444
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/10/2025

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: 381044
• Device Lot Number: 5037132
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 10/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2025
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown