MAUDE Adverse Event Report: BECTON DICKINSON SAF-T-INTIMA W/Y ADAPTER BL 22GA X .75IN; INTRAVASCULAR CATHETER

Catalog Number	383323
Medical Device Problem Codes	Fluid/Blood Leak (1250); Leak/Splash (1354); Material Separation (1562); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation results: a complaint history review cannot be performed as no batch/lot number was provided.A device history record (dhr) review could not be performed as no batch/lot number was made available for this reported event.A review of the applicable risk document indicates that the potential risk of the reported event was assessed appropriately in the risk management documentation.A retain sample analysis could not be performed as no batch/lot number was made available for this reported event.Root cause couldn't be determined due to unavailability of sample and batch/lot number information.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.B3.The date received by manufacturer has been used for this field.
Event or Problem Description
Material#: 383323.Batch#: 4326884.It was reported by the customer that chemotherapy infusing after double check.About an hour into the infusion, pt noticed that the iv catheter was leaking blood and chemotherapy.Infusion paused.Iv pressure cap popped off of iv catheter.

• Brand Name: SAF-T-INTIMA W/Y ADAPTER BL 22GA X .75IN
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 23570054
• Report Number: 9610847-2025-00424
• Device Sequence Number: 21313420
• Product Code: FOZ
• UDI-Device Identifier: 00382903833238
• UDI-Public: (01)00382903833238
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K013800
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2025

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: 383323
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2025
• Supplement Date Received by Manufacturer: 12/30/2025
• Initial Report FDA Received Date: 11/17/2025
• Supplement Report FDA Received Date: 01/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown