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	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd saf-t-intima w/y adapter yel 24ga x.75i tubing seperated from adaptor / luer connector and leaked side injector of catheter disconnected, causing chemotherapy spillage.Quantity: 01 anvisa notification: no.Sample availability: no, presence of biological material was it being used on patient at the time? yes.Was patient harmed? no.When was the problem detected? after the medicine was leaking.
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
Additional information received on 02/24/2025.Could you please share the photo samples related to this event? a: yes, photo samples are attached.Can you please confirm the date of event? a: 04/02/2025.Was there any damage sustained to the device during use? if so, approximately where? how was the damage identified? a: yes, on the side injector, causing the medication to spill.Was the device used for multiple punctures? a: no.Was a syringe or powered injector used to force fluid through the device? a: no.No additional information provided.
Additional Manufacturer Narrative
Dhr review: the complaint lot#: 3333002, assembly in suzhou plant on 2023.Dec.15, 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 samples returned; picture provided to show prn is dropped with a used product.Retain sample analysis: sampling 2ea from the retain sample of the same manufacture lot to check vent plug and prn connector assembly status and do leakage test, all of them are within specification, refer to the attachment for retain sample test report.Possible cause analysis: the reported information describe connector drop (cannot ensure it¿s the vent plug or prn connector), possible reason of such type of defect will be: 1.Poor assembly status, vent plug assembly too loose, or prn connector torque is too low.2.Other abnormal vibration or movement that cause component become loose.Manufacture process have the operation as below to prevent the risk above: 1.100% inspection during each manual assembly station can detect any component loose defect, packaging line can detect such defect as well during manual loading.2.Prn torque and leakage test can monitor any poor assembly defect.Conclusion: there is only one picture provided to show prn is dropped with a used product, and retained samples cannot detect the defect as reported, with this we cannot identify the root cause for this case.

• 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: 21446632
• Report Number: 3002601200-2025-00070
• Device Sequence Number: 12552327
• Product Code: FOZ
• UDI-Device Identifier: 00382903833139
• UDI-Public: (01)00382903833139(11)231129(17)271130(10)3333002
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2025

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: Health Professional
• Device Catalogue Number: 383313
• Device Lot Number: 3333002
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2025
• Supplement Date Received by Manufacturer: 03/07/2025
• Initial Report FDA Received Date: 02/24/2025
• Supplement Report FDA Received Date: 03/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown