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

Catalog Number	383323
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that bd saf-t-intima w/y adapter bl 22ga x.75in - leakage.It was reported that with a certain frequency that the intima rubber has broken when the contrast is injected into the infusion pump, which is in the other pathway where the clave is located.The patient's case was reported today but remember that it wasn't the first time.Customer reports leaking intima rubber at the time of contrast infusion.
Additional Manufacturer Narrative
Additional information: (b) included additional responses provided by the complainant.Investigation results: review the in-process test record and outgoing test report, all test results meet the product specifications, no abnormal found.Review the product assembly record, no non-conformities, deviations or rework activities for this lot.Based on the reported information, a leakage detected around rubber, the possible reason is as below: 1.The raw material has defect 2.Component damage happened during assembly current manufacture process has taken control procedures as below to protect this kind of possible risk: 1.100% common inspection is performed during each process station start from tubing bonding process 2.Common inspection is performed during packaging process 3.Qc sampling check will inspect the component appearance and do leakage test the retained sample appearance inspection and leakage test result are within specification, with this we cannot decide the root cause.
Event or Problem Description
Additional information: the amount of contrast the patient receives may be less, there have been at least three cases in recent times.

• 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 (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 22888677
• Report Number: 3006948883-2025-00535
• Device Sequence Number: 20062424
• Product Code: FOZ
• UDI-Device Identifier: 00382903833238
• UDI-Public: (01)00382903833238(17)280630(10)4171437
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K013800
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2025

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: 4171437
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2025
• Supplement Date Received by Manufacturer: 10/28/2025
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/19/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown