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

Catalog Number	382912
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/19/2024
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.
Event or Problem Description
It was reported that bd insyte ag bc global wing catheter is defective.The following information was provided by the initial reporter, translated from italian to english: incident description: emergency situation in an emergency room: paediatric patient severely burnt, several attempts at venous cannulation with the device were performed by experienced health personnel (paediatrician, doctor anaesthetist, neonatologist, paediatric nurse) were unsuccessful.The reasons were: a.Difficulties in the skin transition.B.Plastic sheath of the needle permanently in the vein curls or has a break in continuity.C.The end opposite the needle, i.E.The piece to be extracted is too long and too heavy, alters the balance and grip channelling, making it unsuitable for the ends hand and foot.D.High resistance to blood flow within plastic lumen probably due to the fact that the lumen in tip has a diameter ni are: greater than the lumen of the base.Device availability: yes.Place availability: the device is not available.Are available in uo ps pieces from the same batch.Any other information the reporter wishes to provide to the ministry of health: health personnel have complained extensively about the catheter in question as there have already been incidents of difficulty in cannulation in paediatric patients.Actions taken: the venous vessel could not be found and an intraosseous infusion had to be applied, which has more complex risks and management than cannulation of a peripheral vessel both the short and long term.
Additional Manufacturer Narrative
Investigation results: a device history record review was completed by our quality engineer team for provided material number 382912 and lot number 2279392.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect 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 additional information.

• 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: 21137457
• Report Number: 1710034-2025-00008
• Device Sequence Number: 6806990
• Product Code: FOZ
• UDI-Device Identifier: 00382903829125
• UDI-Public: (01)00382903829125(11)221007(17)250930(10)2279392
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2025

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 Expiration Date: 09/30/2025
• Device Catalogue Number: 382912
• Device Lot Number: 2279392
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2024
• Supplement Date Received by Manufacturer: 03/07/2025
• Initial Report FDA Received Date: 01/13/2025
• Supplement Report FDA Received Date: 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown