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

Catalog Number	383323
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2025
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 tubing was defective/damaged it was reported that "hole in the esxtension of the device, the leaking occurred when the cateter was installed, on the return there was already a leak, lot number 4081414, product purchased from the manufacturer itself.
Additional Manufacturer Narrative
Dhr review: the complaint lot# 4081414, sku is (b)(4), assembly in suzhou plant1 on 2024.Apr.8, a planned 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: picture provided and showing leaking on the extension tubing.Retain sample analysis: sampling 2ea from the retain sample of the same lot to do leakage test, result is within specification as well.Refer to the attachment for retain sample test report.Possible cause analysis: based on the reported information, damage is detected on catheter and cause a 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.We cannot identify which step causes the damage or it's a raw material defect.The retained sample appearance inspection and leakage test is performed, not defect detected, with this we cannot decide the root cause, only analyze possible reasons.
Event or Problem Description
No additional information available.

• 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: 22842309
• Report Number: 3006948883-2025-00499
• Device Sequence Number: 4849194
• Product Code: FOZ
• UDI-Device Identifier: 00382903833238
• UDI-Public: (01)00382903833238(17)280331(10)4081414
• 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): 09/22/2025

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: 4081414
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2025
• Supplement Date Received by Manufacturer: 09/22/2025
• Initial Report FDA Received Date: 08/19/2025
• Supplement Report FDA Received Date: 09/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown