MAUDE Adverse Event Report: BECTON DICKINSON SAF-T-INTIMA; INTRAVASCULAR CATHETER

Catalog Number	383323
Medical Device Problem Codes	Retraction Problem (1536); Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2025
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.B3.The date received by manufacturer has been used for this field.
Event or Problem Description
It was reported by customer that "when needle pulled back into safety mechanism, needle went through rubber plunger exposing needle with patient's blood." no harm to patient or staff.Rn placing an iv with the saf-t intima safety system with y adapter and when needle pulled back into safety mechanism, needle went through rubber plunger exposing needle with patient's blood.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Correction: (d) lot # is unknown.Investigation results: the reported defect could not be refuted nor confirmed in the absence of a sample.The root cause cannot be determined for an unconfirmed defect.A complaint history check was not performed as the lot number is unknown for this complaint.A device history record review was not performed as the lot number is unknown for this complaint.A review of the applicable risk document indicates that the potential risk of the reported event was assessed appropriately in the risk management documentation.

• Brand Name: SAF-T-INTIMA
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 23220639
• Report Number: 9610847-2025-00357
• Device Sequence Number: 18650428
• Product Code: FOZ
• UDI-Device Identifier: 00382903833238
• UDI-Public: (01)00382903833238(10)505027
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 11/03/2025

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: UNKNOWN
• 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: 09/17/2025
• Supplement Date Received by Manufacturer: 10/31/2025
• Initial Report FDA Received Date: 10/06/2025
• Supplement Report FDA Received Date: 11/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown