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

Catalog Number	383323
Medical Device Problem Code	Material Integrity Problem (2978)
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, separation adapter from tubing.Started iv on patient with a 22 g saf-t-intima.When clamping the tubing after flushing, the entire tubing piece came disconnected from the blue y-site.The iv had to be removed and another iv placed so the patient could receive treatment.
Additional Manufacturer Narrative
Dhr review: the complaint lot# is 4354067, sku is 383323, assembly in suzhou plant on 2025.Jan.6, a planned 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 picture or sample provided.Retain sample analysis: sampling 2ea from the retain sample of the same lot to check component assembly status and do leakage test, test result is within product specification.Possible cause analysis: based on the information, tubing and adapter are separated during using.The possible reasons for this type of failure may including: 1.Poor swaging performance between tubing and adapter.2.Extension tubing was damaged.Current manufacture already has control procedures as below to monitor and prevent this kind of defect: 1.Both in-process and outgoing sampling will check the pull force related extension tubing and adapter.2.Both in-process and outgoing sampling check do leakage test for component of extension tubing and adapter.Conclusion(s): there is no picture or defect sample provided, and the retain sample test result is pass, so the root cause is not clear for this 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: 22893751
• Report Number: 3006948883-2025-00538
• Device Sequence Number: 8957673
• Product Code: FOZ
• UDI-Device Identifier: 00382903833238
• UDI-Public: (01)00382903833238(17)281231(10)4354067
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K013800
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2025

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: 4354067
• 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: 08/19/2025
• Supplement Date Received by Manufacturer: 09/26/2025
• Initial Report FDA Received Date: 08/26/2025
• Supplement Report FDA Received Date: 10/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/19/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown