MAUDE Adverse Event Report: BD (SUZHOU) BD SAF-T-INTIMA W/Y ADAPTER YEL 24GA X .75I; INTRAVASCULAR CATHETER

Catalog Number	383313
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.The date received by manufacturer has been used for this field.E.1.Address was not located and il was used.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 the bd saf-t-intima w/y adapter yel 24ga x.75i had leakage at the adapter tubing junction.The following information was provided by the initial reporter: material #383313, lot #4351793.Verbatim: rcc received a complaint via email.Using saf-t intima sq infusion catheter, noted at initial push of darzalex, tubing leaking at tubing y site.Wrapped with opposite to continue infusion to conclusion.Lot #: 4351793, ref: 383313.
Event or Problem Description
No additional information available.
Additional Manufacturer Narrative
Dhr review: the complaint lot# is 4351793, sku is 383313, assembly in suzhou plant on 2024.Dec.25, lot quantity is (b)(4) ea.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 sample available.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 and y 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.Defect sample is not available, and the retain sample leakage test result is pass, so the root cause is not clear for this leakage issue.

• Brand Name: BD SAF-T-INTIMA W/Y ADAPTER YEL 24GA X .75I
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• 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: 22066864
• Report Number: 3006948883-2025-00152
• Device Sequence Number: 18334520
• Product Code: FOZ
• UDI-Device Identifier: 00382903833139
• UDI-Public: (01)00382903833139(11)241216(17)281130(10)4351793
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2025

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: Other
• Device Catalogue Number: 383313
• Device Lot Number: 4351793
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2025
• Supplement Date Received by Manufacturer: 07/08/2025
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 07/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown