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

Catalog Number	383323
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2025
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 safety shield activation failed it was reported by customer that the needle was not retracting from catheter per usual methods once blood flash was noted verbatim: i¿m reaching out regarding a safety incident that involved bd item # (b)(6) (saf-t-intima integrated catheter system with y adapter, blue, 22g x 0.75").Please see noteworthy event details below: 1.Description: while placing bd saf-t-intima iv, this rn noted that needle was not retracting from catheter per usual methods once blood flash was noted.Iv was then removed from pt's arm and catheter noted to be split and to the right with needle intact and straight.Lot 4298267.Gauze placed to pt's arm over access site and situation explained to patient.2.The event occurred on (b)(6) 2025.3.The lot number was 4298267.4.The defective item was not saved and cannot be sent for further assessment.5.Harm level: no harm to patient or clinical staff.
Additional Manufacturer Narrative
Dhr review: the complaint lot# is 4298267, sku is 383323, assembly in suzhou plant on 2024.Nov.20, 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.Returned sample analysis: no sample returned.Retain sample analysis: sampling 2ea from the retain sample of the same lot to check product function, product safety shield activation function is good.Refer to the attachment for retain sample test report.Possible cause analysis: based on the reported information, needle is exposure to air.Possible reasons for this type of failure may including: 1.The assembly status between outer shield and rubber is not good, the rubber is not pressed to the end during assembly 2.Product safety shield is pulled during manual assembly flow or manual packaging.Thess risk will cause the outer shield drops off before the needle retracted completely.Current manufacture already has control procedures as below to defect and prevent this kind of defect: 1.100% inspection for the gap between outer and rubber is performed at the last station of assembly.2.Both in-process and outgoing sampling check will test the separation force between rubber and outer shield.There is no picture provided, we cannot identify the actual defect feature, cannot determine whether it¿s a poor assembly issue or raw material issue, so the root cause of this case is not clear.Based on the ifu description, hold the puller and keep the component adown can activate needle safety function successfully.
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: 22689076
• Report Number: 3006948883-2025-00353
• Device Sequence Number: 18209835
• Product Code: FOZ
• UDI-Device Identifier: 00382903833238
• UDI-Public: (01)00382903833238(17)281031(10)4298267
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K013800
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2025

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: 4298267
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2025
• Supplement Date Received by Manufacturer: 08/20/2025
• Initial Report FDA Received Date: 08/01/2025
• Supplement Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown