MAUDE Adverse Event Report: BD SUZHOU (MDS) SAF-T-INTIMA; INTRAVASCULAR CATHETER

Catalog Number	383313
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd saf-t-intima w/y adapter yel 24ga x.75i stylet damaged / defective complaint: guide wire broke during puncture inside the silicone wire, part of which got stuck inside and part of which was removed add info received on (b)(6) 2025.Is there any impact on patients? if yes, please explain in detail? no.Has anvisa been notified? if yes, what was the notification number? yes, nt141529.Could you provide the date the event occurred? (b)(6) 2025.Could you confirm the quantity affected? 01.Is the sample related to this incident available for analysis? if so, please answer the questions below.Not available.
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
No additional information is available.
Additional Manufacturer Narrative
Dhr review: the complaint lot#4171464, assembly in suzhou plant on 2024.Jul.17, 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 returned sample retain sample analysis: sampling 2ea from the retain sample of the same manufacture lot to check product cannula tip status, the cannula tip status is good, and no defect detected, the puncturing function is also within specification.Possible cause analysis: the complaint reports that needle is not withdrawn together with guide wire, the possible cause of this defect is that crimping condition between stylet and needle is not good.Current manufacture process have control procedures as below to protect this kind of possible cause: 1.After stylet/needle crimping process, 100% inspection is performed for the crimping status.2.Check the pull force between stylet (guide wire) and needle at the beginning of each shift.3.Qc in-process sampling check the pull force above, and sampling check the finish goods after eo for this item as well.Conclusion: as conclusion, we cannot clarify the actual defect feature, but sampling check the retained sample, all related items are within product specification, so the root cause is not clear.

• Brand Name: SAF-T-INTIMA
• 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: 22372492
• Report Number: 3006948883-2025-00255
• Device Sequence Number: 8016933
• Product Code: FOZ
• UDI-Device Identifier: 00382903833139
• UDI-Public: (01)00382903833139(11)240619(17)280630(10)4171464
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Pharmacist
• 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: Health Professional
• Device Catalogue Number: 383313
• Device Lot Number: 4171464
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2025
• Supplement Date Received by Manufacturer: 07/08/2025
• Initial Report FDA Received Date: 07/01/2025
• Supplement Report FDA Received Date: 07/11/2025
• 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