MAUDE Adverse Event Report: BECTON DICKINSON SAF-T-INTIMA W/Y ADAPTER BL 22GA X .75IN; INTRAVASCULAR CATHETER

Catalog Number	383323
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient is intubated, and a small hole is observed in the line through which blood is overflowing.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
Dhr review: the complaint lot# is 4199689, sku is 383323, assembly in suzhou plant on 2024.Aug.13, a planned lot quantity of (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: the customer provided two pictures; one showing the used complaint unit placed inside the unit packaging.The complaint unit was returned.Two wounds were observed in the extension tubing of the returned complaint unit.Retain sample analysis: sampling 2ea from the retained samples of the same lot to do inspection and leakage test, the test result is within product specifications.Possible cause analysis: based on the reported information and analysis of the complaint unit, the extension tubing is damaged.The possible reasons for tubing damage during manufacturing include: 1.Incoming tubing is damaged/broken.2.Tubing was damaged or broken by the clamper during auto adapter swaging process.Current manufacturing already has control procedures as below to monitor and prevent this kind of defect: 1.Incoming quality check can detect and control the risk of raw material damage.2.Both in-process and outgoing sampling does inspection and leakage test for extension tubing.Tubing damage by the clamper during auto adapter swaging process can be detected.Conclusion(s): there is no abnormality found in the manufacturing records and the retained sample test results pass, so the root cause is not clear for the reported issue.
Event or Problem Description
No additional information is available.

• Brand Name: SAF-T-INTIMA W/Y ADAPTER BL 22GA X .75IN
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• 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: 23414310
• Report Number: 3006948883-2025-00811
• Device Sequence Number: 18399172
• Product Code: FOZ
• UDI-Device Identifier: 00382903833238
• UDI-Public: (01)00382903833238(17)280731(10)4199689
• Combination Product (Y/N): N
• Initial Reporter Country: PE
• PMA/510(K) Number: K013800
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2026

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: 4199689
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2025
• Supplement Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown