MAUDE Adverse Event Report: BD (SUZHOU) BD SAF-T-INTIMA W/PRN YEL 24GA X .75IN; INTRAVASCULAR CATHETER

Catalog Number	383312
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.The date received by manufacturer has been used for this field.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 the bd saf-t-intima w/prn yel 24ga x.75in catheter broke / separated after placement.The following information was provided by the initial reporter translated from portuguese to english: catheter broke when activating the device, another broke when clamping, and another came with a cut bevel.All were 24 gauge.Oncology, first floor, infusion center.This complaint was made during the training of the intima itself, but they did not keep the material, did not report it before, and do not know the date or batch of the catheter.Had no impact.
Additional Manufacturer Narrative
No manufacture lot # provided, factory cannot do related investigation including dhr review risk review, retain sample analysis.Returned sample analysis: two pictures attached and shows the luer-adapter was separated from tubing.Possible cause analysis: extension tubing raw material defect.Luer-adapter poor swaging issue.Ext-tubing poor flaring issue.Current manufacture has control procedure as below to prevent possible causes above: incoming inspection can detect a raw material issue.In-process and outgoing sampling check will do pull force test and leakage test to monitor extension tubing flaring issue and luer-adapter swaging issue.There is no manufacture lot#, we cannot review the manufacture information, analysis is for possible causes as well, the root cause is not clear.
Event or Problem Description
No additional information available.

• Brand Name: BD SAF-T-INTIMA W/PRN YEL 24GA X .75IN
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• 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: 22005774
• Report Number: 3006948883-2025-00132
• Device Sequence Number: 9201808
• Product Code: FOZ
• UDI-Device Identifier: 00382903833122
• UDI-Public: (01)00382903833122
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2025

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: 383312
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2025
• Supplement Date Received by Manufacturer: 06/18/2025
• Initial Report FDA Received Date: 05/12/2025
• Supplement Report FDA Received Date: 06/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown