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

Catalog Number	381044
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2025
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
On two occasions one of the staff has noticed when she goes to retract the needle that it almost pulls the whole cannula out of the iv site.She wonders if there is a little burr and it is getting caught on the plastic cannula.No adverse event reported.
Event or Problem Description
Customer response on (b)(6) 2025.1.Could you please provide the exact event date in the format (mm-dd-yyyy) for both occurrences? (b)(6) 2025.2.Does the needle fail to retract? no.3.If yes, does the needle partially retract, slowly retract, or not retract at all? the needle fully retracted but it got caught on the canula on the way out pulling the cannula out with it.4.Is there any visible catheter damaged when it appears to be caught on the needle? the nurse caught the cannula on the way out before it was totally out and was threaded back in.5.Is there any harm/serious injury to patient? no harm to the patient.
Additional Manufacturer Narrative
Additional information received including clarification of event date.
Additional Manufacturer Narrative
A device history record review was completed by our quality engineer team for provided material number 381044 and lot number 5073797.The review did not reveal any detected abnormalities during the production process that could have contributed to the reported issue, and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.
Event or Problem Description
No new information.

• 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: 23039692
• Report Number: 1710034-2025-01512
• Device Sequence Number: 10143267
• Product Code: FOZ
• UDI-Device Identifier: 00382903810444
• UDI-Public: (01)00382903810444
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/30/2025

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: 5073797
• 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: 08/29/2025
• Supplement Date Received by Manufacturer: Not provided; 09/30/2025
• Initial Report FDA Received Date: 09/12/2025
• Supplement Report FDA Received Date: 09/15/2025; 10/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/19/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown