MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE AG BC 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	05/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd insyte ag bc global wing needle did not retract.The following information was provided by the initial reporter: bd has determined that when inserting the catheter, the needle retracts slowly or does not retract at all.Slow or no retraction may result in repeated attempts to retract the needle by pressing the button.It is also possible that a needle may remain exposed despite attempts to cover it.
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.
Additional Manufacturer Narrative
Correction: cancel mdr clarifying information received: 1-jul-2025 ¿ complaint to be cancelled.Not a complaint from a customer.The sales rep only shares the recent field action mds_25_5274 as it suspected complaint was related to this fsca.Intake team erroneously created 3 new complaints based on the bd field action document.
Event or Problem Description
Clarifying information received: 1-jul-2025 ¿ complaint to be cancelled.Not a complaint from a customer.The sales rep only shares the recent field action mds_25_5274 as it suspected complaint was related to this fsca.Intake team erroneously created 3 new complaints based on the bd field action document.

• Brand Name: BD INSYTE AG BC 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: 22196595
• Report Number: 1710034-2025-00989
• Device Sequence Number: 15771692
• Product Code: FOZ
• UDI-Device Identifier: 00382903829446
• UDI-Public: (01)00382903829446(11)241105(17)270930(10)4298108
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2025

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2025
• Supplement Date Received by Manufacturer: 07/03/2025
• Initial Report FDA Received Date: 06/12/2025
• Supplement Report FDA Received Date: 07/07/2025
• 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