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

Catalog Number	382933
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd iag bc pro global wing leaked.The following information was provided by the initial reporter, translated from french to english: circumstances of occurrence / description of facts: when placing a short 20g 25mm catheter on a patient, a leakage was observed on the catheter adapter between catheter and non-return valve (see appendix).By consequently, the catheter was immediately removed and a blood flowed onto the nurse.Another catheter was replaced.The nurse also told us that other patients' dressings were more soiled than usual, suggesting that leakage had also occurred with other catheters of the same reference.Clinical consequences: painful procedure for the patient riak accident exposition of blood (aes) for the nurse extended patient intervention time temporary damage, disorganization.
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.B3.The date received by manufacturer has been used for this field.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Investigation results: the complaint of a leak could not be confirmed from the photograph that was provided for investigation.The photograph showed a 20g insyte autoguard iv catheter positioned on a white background with an arrow pointing to the catheter adapter.No leaks could be identified from the catheter adapter.No damage or defects were identified on the device.Although the photograph does not support the complainant¿s description of the reported event, the complaint has been documented and will continue to be monitored as part of ongoing efforts to identify potential manufacturing related issues.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.

• 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: 21448157
• Report Number: 1710034-2025-00300
• Device Sequence Number: 17971848
• Product Code: FOZ
• UDI-Device Identifier: 00382903829330
• UDI-Public: (01)00382903829330
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2025

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: 382933
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2025
• Supplement Date Received by Manufacturer: 03/10/2025
• Initial Report FDA Received Date: 02/24/2025
• Supplement Report FDA Received Date: 03/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown