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

Catalog Number	382923
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/31/2024
Type of Reportable Event	Malfunction
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.An additional lot number was provided in this complaint for material number 382923.Lot # 4046220 mnf date 2024-02-21 exp date 2027-01-31.
Event or Problem Description
It was reported that bd iag bc pro global wing catheter releases prematurely.The following information was provided by the initial reporter: 1.Even with a good insertion technique patient is experiencing severe pain.2.The cannula is in the vein but doesn¿t advance and no back flow.3.When inserting the canula the canula turns around the needle hence no stability when attempting to thread the canula.Patient is experiencing severe pain, no back flow and cannula isn't stable.When did the incident occur? during use.
Additional Manufacturer Narrative
Investigation results: no photographic evidence or physical samples were submitted for the investigation of the reported condition.A comprehensive examination of the device's history was performed for the iag bc pro global wing bl 22ga x 1.0in lots: 4065640 and 4046220.The review of the device history record revealed no non-conformance's linked to this issue during the production of lot: 4046220.A quality notification concerning the reported defect was initiated during the manufacturing of lot: 4065640.However, in the absence of a sample, we are unable to confirm a connection between this failure and the notification.Given the information at hand, a definitive cause for this incident could not be determined.
Event or Problem Description
No additional information.

• Brand Name: BD 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: 20726581
• Report Number: 1710034-2024-01360
• Device Sequence Number: 18377937
• Product Code: FOZ
• UDI-Device Identifier: 00382903829231
• UDI-Public: (01)00382903829231(11)240306(17)270228(10)4065640
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2025

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: Other
• Device Catalogue Number: 382923
• Device Lot Number: 4065640
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2024
• Supplement Date Received by Manufacturer: 02/05/2025
• Initial Report FDA Received Date: 11/19/2024
• Supplement Report FDA Received Date: 02/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown