BD Saf-T-Intima 383336Recalls & reported problems

Summary

The FDA's MAUDE database contains 71 adverse event reports that list this exact device (DI 00382903833368), received between Dec 8, 2017 and Feb 25, 2026 — classified as 8 injuries, 63 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (30 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 71 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 25, 2026Leak/Splash; Material Split, Cut or Torn

  IT WAS REPORTED THAT AFTER PUNCTURING THE PATIENT, BLOOD LEAKED THROUGH THE EXTENSION. A HOLE WAS FOUND IN THE EXTENSION OF THE INTIMA. QUANTITY: 01. BATCH NUMBER(S): 4262695. IS A SAMPLE AVAILABLE: NO. DATE OF OCCURRENCE: (B)(6) 2026. ADDITIONAL INFORMATION RECEIVED ON 12-FEB-2026: WAS THERE ANY DAMAGE TO THE PATIENT'S HEALTH: NO. WAS THE INCIDENT REPORTED TO ANVISA? IF SO, WHAT IS THE NOTIFICATION NUMBER: NO. COULD YOU SHARE A PHOTO/VIDEO OF THE REPORTED EVENT: THE REPORTING SECTOR DID NOT RECORD A PHOTO OR VIDEO OF THE INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24443931 ↗
• MalfunctionJul 16, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT BD SAF-T-INTIMA W/Y ADAPTER PNK 20GAX1.0IN LEAKED IT WAS REPORTED BY CUSTOMER THAT 20 GAUGE IV PLACED IN R FOREARM. GOOD BLOOD RETURN NOTED. WIRE REMOVED. BLOOD NOTED ON TUBING. WHEN FLUSHED, BLOOD AND SALINE LEAKED FROM TUBING. IV INSERTION SITE INTACT. IV PULLED OUT. TUBING APPEARED TO LEAK JUST ABOVE BUTTERFLY WINGS. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. I¿M REACHING OUT REGARDING A SAFETY INCIDENT THAT INVOLVED BD ITEM # 383336 (SAF-T-INTIMA INTEGRATED CATHETER SYSTEM WITH Y ADAPTER, PINK, 20G X 1"). PLEASE SEE NOTEWORTHY EVENT DETAILS BELOW: 1. DESCRIPTION: 20 GAUGE IV PLACED IN R FOREARM. GOOD BLOOD RETURN NOTED. WIRE REMOVED. BLOOD NOTED ON TUBING. WHEN FLUSHED, BLOOD AND SALINE LEAKED FROM TUBING. IV INSERTION SITE INTACT. IV PULLED OUT. TUBING APPEARED TO LEAK JUST ABOVE BUTTERFLY WINGS. PACKAGE SAVED. 2. THE EVENT OCCURRED ON 5/31/2025. 3. THE LOT NUMBER WAS 4145188. 4. THE DEFECTIVE ITEM WAS NOT SAVED AND CANNOT BE SENT FOR FURTHER ASSESSMENT. 5. HARM LEVEL: NO HARM TO PATIENT OR CLINICAL STAFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22522355 ↗
• MalfunctionApr 24, 2025Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21900943 ↗
• MalfunctionJan 3, 2025Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21069445 ↗
• MalfunctionDec 29, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD SAF-T-INTIMA W/Y ADAPTER PNK 20GAX1.0IN LEAKAGE. ON (B)(6) 2024, AFTER PERFORMING A VENIPUNCTURE ON A PATIENT WITH A 20GBD INDWELLING NEEDLE, IT WAS DISCOVERED THAT BLOOD WAS LEAKING FROM THE MIDDLE OF THE NEEDLE, WHICH RESULTED IN A CONSTANT LEAKAGE DURING THE INFUSION PROCESS, THE NEEDLE WAS IMMEDIATELY REPLACED AND RE-PUNCTURED AND WAS ALSO REPORTED TO THE EQUIPMENT SECTION.

  Patient problems: Fluid Discharge

  MAUDE report 21032694 ↗
• InjuryNov 29, 2023Break; Break

  IT WAS REPORTED THAT BD SAF-T-INTIMA W/Y ADAPTER PNK 20GAX1.0IN NEEDLE BROKE AFTER SUCCESSFUL PUNCTURE OF THE INDWELLING NEEDLE, THE GUIDEWIRE WAS BROKEN WHEN RETIRING THE GUIDEWIRE DURING TUBE PLACEMENT, AND PART OF THE GUIDEWIRE WAS RETAINED IN THE INDWELLING NEEDLE; THE RETAINED BROKEN GUIDEWIRE WAS LATER REMOVED WITH FORCEPS AND REPORTED WITHOUT ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18233603 ↗
• InjuryNov 20, 2023Break; Break

  THE INCIDENT OCCURRED IN THE OPERATING THEATRE, A SECTION WAS FOUND TO BE BROKEN IN THE BODY DURING THE WITHDRAWAL OF THE NEEDLE, THE HOSPITAL IS REQUIRED TO REPORT AN ADVERSE EVENT, THE RESPONSE TO THIS MATTER HAS BEEN VERY STRONG, THE IMPACT IS VERY BAD, AND WE HOPE THAT IT WILL BE DEALT WITH AS SOON AS POSSIBLE. NUMBER OF AFFECTED ONE UNIT/NEED FOR GREEN CLAIM/NEED FOR COMPLAINT REPLY LETTER/NEED FOR COMPLAINT ACCEPTANCE LETTER/SAMPLE COULD NOT BE RETURNED/PHOTOGRAPHS AVAILABLE COMMUNICATED BY PHONE, THE SAMPLE COULD NOT BE RETURNED, THE BROKEN NEEDLE WAS REMOVED, AND THE PATIENT'S MENTAL STATUS WAS NORMAL AT THE TIME OF PUNCTURE

  Patient problems: Insufficient Information

  MAUDE report 18176967 ↗
• MalfunctionSep 15, 2023Material Separation; Material Separation

  IT WAS REPORTED WHILE USING BD SAF-T-INTIMA¿ CLOSED IV CATHETER SYSTEM 20 G X 1.00 IN. THE PRN SEPARATED FROM THE DEVICE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER PLACEMENT, WHEN PULLING OFF THE SHIELD THE ENTIRE SHIELD AND CAP SEPARATED FROM THE DEVICE. THE DEVICE WAS REPLACED AND THERE WAS NO FURTHER PATIENT IMPACT. NO PHOTOS OR SAMPLE AVAILABLE. LOT# 1053944.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17757118 ↗
• MalfunctionAug 2, 2023Fluid/Blood Leak; Defective Component; Fluid/Blood Leak; Defective Component

  IT WAS REPORTED THAT THE BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM WAS DAMAGED CAUSING LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: THERE WAS A HOLE IN DEVICE'S EXTENSION, CAUSING A BLOOD LEAKAGE AFTER PUNCTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17445610 ↗
• MalfunctionAug 1, 2023Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT THE BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM EXPERIENCED SAFETY MECHANISM FAILURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: AN ATTEMPT WAS MADE IN OBS ROOM 13 TO INSTALL A PERIPHERAL VENOUS ACCESS, WITH INTIMA 20 FROM THE BD SALF-T-INTIMA BRAND, IN WHICH DURING THE CATHETER INSERTION PROCEDURE, THE SAFETY DEVICE FAILED, BECAUSE WHEN TRYING TO REMOVE THE NEEDLE, EVEN PRESSING THE FIXATION WING, THE CATHETER WAS REMOVED COMPLETELY WITH SILICONE AND EXPOSED NEEDLE PASSING UNDER THE PROFESSIONAL'S FINGER, WITHOUT OCCURRENCE OF AN ACCIDENT AT WORK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17436296 ↗
• InjuryFeb 23, 2023Fail-Safe Problem; Fail-Safe Problem

  IT WAS REPORTED THAT THE BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM SAFETY MECHANISM FAILED AND A NEEDLE STICK INJURY OCCURRED AS A RESULT. NO FURTHER INFORMATION WAS PROVIDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE SAFT-INTIMA DEVICE FAILED AND A NEEDLESTICK INJURY OCCURRED."

  Patient problems: Needle Stick/Puncture

  MAUDE report 16433366 ↗
• InjuryFeb 23, 2023Fail-Safe Problem; Fail-Safe Problem

  IT WAS REPORTED THAT THE BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM SAFETY MECHANISM FAILED AND A NEEDLE STICK INJURY OCCURRED AS A RESULT. NO FURTHER INFORMATION WAS PROVIDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE SAFT-INTIMA DEVICE FAILED AND A NEEDLESTICK INJURY OCCURRED."

  Patient problems: Needle Stick/Puncture

  MAUDE report 16433343 ↗
• InjuryFeb 23, 2023Fail-Safe Problem; Fail-Safe Problem

  IT WAS REPORTED THAT THE BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM SAFETY MECHANISM FAILED AND A NEEDLE STICK INJURY OCCURRED AS A RESULT. NO FURTHER INFORMATION WAS PROVIDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE SAFT-INTIMA DEVICE FAILED AND A NEEDLESTICK INJURY OCCURRED."

  Patient problems: Needle Stick/Puncture

  MAUDE report 16433325 ↗
• MalfunctionFeb 13, 2023Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT THE BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM EXPERIENCED AIR BUBBLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE TWO CATHETERS HAD THE SAME ISSUE DURING OUR OZONE TREATMENT CAUSING A LOT OF BUBBLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16369151 ↗
• MalfunctionFeb 13, 2023Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT THE BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM EXPERIENCED AIR BUBBLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE TWO CATHETERS HAD THE SAME ISSUE DURING OUR OZONE TREATMENT CAUSING A LOT OF BUBBLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16369148 ↗
• MalfunctionJan 11, 2023Retraction Problem; Retraction Problem

  IT WAS REPORTED WHILE USING BD SAF-T-INTIMA¿ CLOSED IV CATHETER SYSTEM THE NEEDLE REMAINED EXPOSED AND LOOSE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: VENOUS PUNCTURE WAS PERFORMED WITH AN INTIMATE DEVICE BATCH 2146218, AFTER THE PUNCTURE WAS COMPLETED, WHEN ACTIVATING THE SAFETY DEVICE, THE NEEDLE DID NOT FIT, LEAVING IT LOOSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16141605 ↗
• MalfunctionDec 20, 2022Loose or Intermittent Connection; Detachment of Device or Device Component; Loose or Intermittent Connection; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM EXPERIENCED A LOOSE NEEDLE, AND THE NEEDLE BEING UNABLE TO DISENGAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAD A RN START AN IV USING THIS PRODUCT AND THE SHARP DID NOT RETRACT APPROPRIATELY. INSTEAD IT WAS LOOSE FROM THE RECEPTACLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16018350 ↗
• MalfunctionDec 20, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED WHILE USING BD SAF-T-INTIMA¿ CLOSED IV CATHETER SYSTEM THE NEEDLES WERE CLOGGED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: IT WAS FOUND THAT THE NEEDLE CORE WAS BLOCKED AND THE FLUID COULD NOT BE DISCHARGED, AND THEN THE PATIENT WAS GIVEN A REPLACEMENT THE INDWELLING NEEDLE DID NOT CAUSE HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16013121 ↗
• MalfunctionDec 19, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT 2 OF THE BD SAF-T-INTIMA¿ CLOSED IV CATHETER SYSTEM LEAKED AT THE JUNCTION OF THE "BUTTERFLY" AND THE EXTENSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: THE CATHETERS SHOWED LEAKAGE AT THE JUNCTION OF THE ¿BUTTERFLY¿ AND THE EXTENSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16009848 ↗
• MalfunctionDec 19, 2022Break; Break

  IT WAS REPORTED WHILE USING BD SAF-T-INTIMA¿ CLOSED IV CATHETER SYSTEM THE NEEDLE BROKE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THEY HAD ISSUES WITH THE BROKEN SAF T INTIMA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16005918 ↗
• MalfunctionDec 13, 2022Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED WHILE USING BD SAF-T-INTIMA¿ CLOSED IV CATHETER SYSTEM IT WAS DAMAGED AND LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REGARDING BROKEN SAF-T-INTIMA ITEMS TODAY. ITEM# 383336. ADDITIONAL INFORMATION RECEIVED 29-NOV-2022 ¿ DO YOU KNOW THE DATE OF EVENT? 11/7/22, 11/15/22, AND 11/21/22 ¿ DO YOU KNOW THAT LOT NUMBER? NO I DON'T KNOW THE LOT NUMBER FOR THE FIRST 2 INCIDENTS. THE THIRD WAS LOT #1287217. ¿ WAS THERE ANY PATIENT IMPACT OR HARM DUE TO THE REPORTED ISSUE? IF SO PLEASE ADVISE IF THERE WAS A NEED FOR ANY MEDICAL TREATMENT OR INTERVENTION NEEDED. YES, THE FIRST 2 INCIDENTS CAUSED CHEMO SPILLS WITH SIGNIFICANT CLEAN UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15970445 ↗
• MalfunctionDec 13, 2022Break; Break

  IT WAS REPORTED BY THE CUSTOMER THAT 3 OF THE BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM WERE BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REACHED OUT TO HER OMITTED REP REGARDING BROKEN SAF-T-INTIMA ITEMS TODAY. ITEM# 383336 WE SPOKE ON THE PHONE AND SAID MADDI IS HOPING TO GET ON THE PHONE WITH AN OMITTED REP TODAY. OMITTED SAID ¿POSSIBLY 4 OR 5¿ BROKEN TODAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15970434 ↗
• MalfunctionDec 13, 2022Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED WHILE USING BD SAF-T-INTIMA¿ CLOSED IV CATHETER SYSTEM IT WAS DAMAGED AND LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REGARDING BROKEN SAF-T-INTIMA ITEMS TODAY. ITEM# 383336. ADDITIONAL INFORMATION RECEIVED 29-NOV-2022: DO YOU KNOW THE DATE OF EVENT? (B)(6) 2022. DO YOU KNOW THAT LOT NUMBER? NO I DON'T KNOW THE LOT NUMBER FOR THE FIRST 2 INCIDENTS. THE THIRD WAS LOT #1287217. WAS THERE ANY PATIENT IMPACT OR HARM DUE TO THE REPORTED ISSUE? IF SO PLEASE ADVISE IF THERE WAS A NEED FOR ANY MEDICAL TREATMENT OR INTERVENTION NEEDED. YES, THE FIRST 2 INCIDENTS CAUSED CHEMO SPILLS WITH SIGNIFICANT CLEAN UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15970368 ↗
• MalfunctionNov 17, 2022Retraction Problem; Retraction Problem

  IT WAS REPORTED BY THE CUSTOMER THAT 2 OF THE BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM CANNOT BE WITHDRAWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: AFTER INJECTION, THE NEEDLE CANNOT BE WITHDRAWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15813095 ↗
• MalfunctionNov 14, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM TUBING SEPARATED FROM THE ADAPTER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE: "DURING PUNCTURE, IT PRESENTED A DEFECT WHEN GUIDEWIRE WAS BEING REMOVED, ONLY THE (BUTTERFLY) ROD STAYED, WITH THE FLEXIBLE TIP INSERTED INTO THE VEIN."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15794317 ↗