MAUDE Adverse Event Report: BECTON DICKINSON BD 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	06/03/2025
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 leaked at adapter tubing junction.Leaking defect in the y connection of the bd saf-t intima product with y adapter.Additional information received on june 10, 2025.Could you please share the customer's name? customer name received.
Additional Manufacturer Narrative
Dhr review: the complaint lot# is 4199689, sku is 383323, assembly in suzhou plant on (b)(6) 2024, lot quantity is (b)(4).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.Returned sample analysis:no picture/video of the complaint unit or the actual complaint unit could be obtained for evaluation.Retain sample analysis: sampling 2ea from the retain sample of the same lot to do leakage test, test result is within product specification.Refer to the attachment for retain sample test report.Possible cause analysis: based on the information, leakage is reported from tubing or y adapter port.The possible reasons for this type of failure may including: 1.Tubing damage/broken issue, or poor prn assembly status.2.The swaging between tubing and luer-adapter is not good, leakage is from the swaging location current manufacture already has control procedures as below to monitor and prevent this kind of defect: 1.Both in-process and outgoing sampling will check the pull force related extension tubing, including the swaging force, a poor connection can be detected 2.Both in-process and outgoing sampling check do leakage test for component with extension tubing and prn connector no picture/video of the complaint unit or the actual complaint unit could be obtained, and the retain sample leakage test result is pass, so the root cause is not clear for this leakage issue.
Event or Problem Description
No additional information available.

• Brand Name: BD 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 21502 1; CH 215021
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 22293423
• Report Number: 3006948883-2025-00211
• Device Sequence Number: 8263470
• Product Code: FOZ
• UDI-Device Identifier: 00382903833238
• UDI-Public: (01)00382903833238(11)240717(17)280731(10)4199689
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2025

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: 4199689
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2025
• Supplement Date Received by Manufacturer: 08/04/2025
• Initial Report FDA Received Date: 06/19/2025
• Supplement Report FDA Received Date: 08/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown