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

Catalog Number	383313
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2025
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 yel 24ga x.75i adapter was defective/damaged product presenting a crack in its connection, which led to the spillage of chemotherapy on the patient.This is the second event with the same lot: 2259640, purchased from the company b&d invoice 767211.Notivisa: (b)(4).
Additional Manufacturer Narrative
Dhr review: the complaint lot#2259640, sku is 383313, assembly in suzhou plant1 on 2022.Oct.20, 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 return sample analysis: no pictures attached to show the actual defect feature.Retain sample analysis: sampling 2ea from the retain sample of the same lot to check product appearance, no defect detected, and leakage test is pass as well.Refer to the attachment for retain sample test report possible cause analysis: based on the reported information, component damage reported and cause to leakage, 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 as conclusion: no picture attached to describe the defect feature, we cannot identify the defect happened at which step, and the retained sample appearance inspection and leakage test is performed, not defect detected, with this we cannot decide the root cause.
Event or Problem Description
No additional information available.

• Brand Name: BD SAF-T-INTIMA W/Y ADAPTER YEL 24GA X .75I
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD SUZHOU (MDS); #5 baiyu road; suzhou industrial park; jiangsu 21502 1; CH 215021
• 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: 21654744
• Report Number: 3002601200-2025-00129
• Device Sequence Number: 7424734
• Product Code: FOZ
• UDI-Device Identifier: 00382903833139
• UDI-Public: (01)00382903833139(11)220916(17)260930(10)2259640
• 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: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2025

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 Expiration Date: 09/30/2026
• Device Catalogue Number: 383313
• Device Lot Number: 2259640
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2025
• Supplement Date Received by Manufacturer: 04/01/2025
• Initial Report FDA Received Date: 03/20/2025
• Supplement Report FDA Received Date: 04/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown