BD Saf-T-Intima 383323Recalls & reported problems
Becton, Dickinson And Company · BD Saf-T-Intima™ Subcutaneous Catheter System Dual Port 22 GA x 0.75 in · Class 2
All models of BD Saf-T-Intima (7)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This BD Saf-T-Intima dual port catheter is a short-term IV tube. Its 256 reports mostly describe leaks of blood or fluid, contamination, and parts breaking or protruding, with some describing the protective shield not activating and a needle stick injury. There were no deaths and 6 injuries, and reports fell to 10 in the last 12 months from 19 in the 12 months before. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 256
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 256 adverse event reports that list this exact device (DI 00382903833238), received between Oct 18, 2017 and Jun 22, 2026 — classified as 6 injuries, 250 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (80 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.
Reports received per month
Most reported problems
Device problems
- Leak/Splash80
- Device Contamination with Chemical or Other Material40
- Break22
- Retraction Problem22
- Material Protrusion/Extrusion17
- Fluid/Blood Leak15
- Detachment of Device or Device Component11
- Material Puncture/Hole11
Patient problems
- No Clinical Signs, Symptoms or Conditions134
- No Known Impact Or Consequence To Patient80
- No Consequences Or Impact To Patient20
- Needle Stick/Puncture7
- No Information5
- No Patient Involvement3
- Exposure to Body Fluids2
- Foreign Body In Patient2
Recent adverse event reports
The 25 most recent of 256 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 22, 2026Leak/Splash; Loose or Intermittent Connection
IT WAS REPORTED BY THE CUSTOMER THAT DUAL PORT IV CATHETER LEAKED BLOOD FROM SECOND PORT ON CATHETER. RN FOUND THE CONNECTION AT THE HUB TO BE LOOSE AND RESULTED IN BLOOD LEAKING OUT. COMPLAINT VIA EMAIL. DUAL PORT IV CATHETER LEAKED BLOOD FROM SECOND PORT ON CATHETER. RN FOUND THE CONNECTION AT THE HUB TO BE LOOSE AND RESULTED IN BLOOD LEAKING OUT. RN STATED THAT THIS HAPPENED 3 TIMES THIS MORNING WITH DIFFERENT IVS ALL WITH THE SAME LOT NUMBER OF 5335830.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25579421 ↗MalfunctionJun 17, 2026Activation Problem
IT WAS REPORTED BY THE CUSTOMER THAT THE SAFETY DEVICE DID NOT ENGAGE. VERBATIM: COMPLAINT VIA EMAIL. RN WENT TO PLACE IV ON PATIENT. AS SHE WAS REMOVING STYLET, THE SAFETY DEVICE DID NOT ENGAGE. REMOVED IV AND ATTEMPTED SUCCESSFULLY WITH NEW DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25535306 ↗MalfunctionMay 5, 2026Leak/Splash
IT WAS REPORTED BY CUSTOMER THAT OBSERVED WITH THE IV CATHETERS, HAD SEVERAL INSTANCES WHERE LEAKAGE OCCURRED FROM THE PORT CIRCLED IN RED. ALTHOUGH THIS PORT ISN¿T ONE USE FREQUENTLY, NURSING STAFF HAVE NOTED THAT IT OFTEN APPEARS LOOSE STRAIGHT OUT OF THE MANUFACTURER¿S PACKAGING. VERBATIM: COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED I WANTED TO FLAG A RECURRING ISSUE WE¿VE OBSERVED WITH THE IV CATHETERS (SEE ATTACHED PHOTO). WE¿VE HAD SEVERAL INSTANCES WHERE LEAKAGE OCCURRED FROM THE PORT CIRCLED IN RED. ALTHOUGH THIS PORT ISN¿T ONE WE USE FREQUENTLY, NURSING STAFF HAVE NOTED THAT IT OFTEN APPEARS LOOSE STRAIGHT OUT OF THE MANUFACTURER¿S PACKAGING. AS A PRECAUTION, OUR TEAM HAS STARTED TIGHTENING THE PORT DURING IV PLACEMENT TO HELP PREVENT ANY LEAKAGE. ALL AFFECTED UNITS APPEAR TO BE FROM THE SAME LOT NUMBER, SO I¿M UNSURE WHETHER THIS RISES TO THE LEVEL OF A FORMAL REPORT. HOWEVER, I SHOULD NOTE THAT THE MOST RECENT INCIDENTS DID RESULT IN CHEMOTHERAPY LEAKAGE.".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25083243 ↗MalfunctionApr 2, 2026Product Quality Problem
IT WAS REPORTED BY THE CUSTOMER THAT THEY HAVE HAD 1 OF THESE CATHETERS THAT HAD A TINY SHAVING OF METAL ATTACHED TO THE TIP OF THE NEEDLE THAT COULD EASILY BREAK OFF. IT APPEARS TO BE AN EXTRA SHAVING/SLIVER THAT WASN¿T REMOVED WHEN THE BEVEL WAS MANUFACTURED. VERBATIM: COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED I WANTED TO REPORT AN ISSUE WITH THE BD SAF-T-INTIMA 22G IV CATHETER, LOT 5259038. WE HAVE HAD 1 THESE CATHETERS THAT HAD A TINY SHAVING OF METAL ATTACHED TO THE TIP OF THE NEEDLE THAT COULD EASILY BREAK OFF. IT APPEARS TO BE AN EXTRA SHAVING/SLIVER THAT WASN¿T REMOVED WHEN THE BEVEL WAS MANUFACTURED. WE WERE ABLE TO CATCH THIS PRIOR TO ANY PATIENT USE, AND WE HAVE OPENED OTHER CATHETERS WITHIN THIS SAME LOT AND THEY HAVE BEEN OK SO FAR. IT WAS VERY DIFFICULT TO GET A GOOD PHOTO DUE TO HOW SMALL THIS SHAVING IS BUT, HOPEFULLY THIS IS HELPFUL. ADDITIONAL INFORMATION RECEIVED ON 24-MAR-2026: 1. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT DD-MMM-YYYY? THIS WAS DISCOVERED ON 3/17/26. 2. CAN YOU SHARE ANY PHYSICAL SAMPLE IF AVAILABLE FOR INVESTIGATION? I STILL HAVE THE IV CATHETER INTACT THAT COULD BE USED AS A PHYSICAL EXAMPLE. 3. ANY ADVERSE EVENT OR SERIOUS INJURY RE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24766466 ↗MalfunctionApr 1, 2026Retraction Problem
NO ADDITIONAL INFORMATION.
Patient problems: Needle Stick/Puncture; No Clinical Signs, Symptoms or Conditions
MAUDE report 24754182 ↗MalfunctionMar 19, 2026
RN REPORTED THAT THE PLASTIC CATHETER COVERING THE NEEDLE ALSO WAS PARTIALLY COVERING THE BEVEL AND SHE WAS UNABLE TO PLACE IV SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24638450 ↗MalfunctionFeb 13, 2026Activation Problem
IT WAS REPORTED BY THE CUSTOMER THAT THE SAFETY MECHANISM DIDN'T ENGAGE & A NEEDLE STICK COULD HAVE OCCURRED. HAD A SAFETY ISSUE W/ AN IV NEEDLE OCCUR TODAY. NO NEEDLE STICK. HOWEVER, SHE STATED THAT THE SAFETY MECHANISM DIDN'T ENGAGE & A NEEDLE STICK COULD HAVE OCCURRED. WE DO NOT HAVE THE LOT # FROM THE PACKAGING, AS IT WAS THROWN AWAY PRIOR TO MY KNOWLEDGE OF THE INCIDENT, AND IT IS AN ENTERIC ISO ROOM. IT WAS A 22G BD SAF-T-INTIMA NEEDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24334914 ↗MalfunctionJan 9, 2026Activation Problem
IT WAS REPORTED THAT BD SAF-T-INTIMA W/Y ADAPTER BL 22GA X .75IN SAFETY SHIELD ACTIVATION FAILED ON (B)(6) 2025 AT APPROXIMATELY 1430, I SUSTAINED A NEEDLESTICK INJURY WHILE AT WORK. ON THIS DAY, MY ROLE WAS BREAK NURSE. A PATIENT REQUIRED IV ACCESS BECAUSE HIS EXISTING LINE WAS NO LONGER FUNCTIONING. I FOLLOWED PROPER PROTOCOL AND SAFETY MEASURES; HOWEVER, DESPITE THESE PRECAUTIONS, I WAS INJURED DURING THE PROCEDURE. THE DEVICE INVOLVED WAS A DEFECTIVE 22G IV BUTTERFLY. ONCE THE CATHETER WAS INSERTED, I MADE AN ATTEMPT TO PULL THE NEEDLE OUT, THE NEEDLE BOUNCED UP AND THE SAFETY MECHANISM NEVER FUNCTIONED. THE NEEDLE WAS FULLY EXPOSED. AFTER THE INCIDENT, I SPOKE WITH MY CHARGE NURSE, WE INFORMED MANAGEMENT AND I HEADED TO THE EMERGENCY DEPARTMENT SHORTLY AFTER. I ALSO SPOKE WITH SEVERAL FELLOW NURSES WHO SHARED THAT THEY HAVE EXPERIENCED SIMILAR INCIDENTS WHILE INSERTING IVS USING THIS DEVICE.
Patient problems: Needle Stick/Puncture
MAUDE report 24022879 ↗MalfunctionNov 17, 2025Fluid/Blood Leak; Leak/Splash; Material Separation; Detachment of Device or Device Component; Fluid/Blood Leak; Leak/Splash; Material Separation; Detachment of Device or Device Component
MATERIAL#: 383323. BATCH#: 4326884. IT WAS REPORTED BY THE CUSTOMER THAT CHEMOTHERAPY INFUSING AFTER DOUBLE CHECK. ABOUT AN HOUR INTO THE INFUSION, PT NOTICED THAT THE IV CATHETER WAS LEAKING BLOOD AND CHEMOTHERAPY. INFUSION PAUSED. IV PRESSURE CAP POPPED OFF OF IV CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23570054 ↗MalfunctionNov 10, 2025Retraction Problem; Activation Problem; Retraction Problem; Activation Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23509458 ↗MalfunctionOct 29, 2025Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole
IT WAS REPORTED THAT THE PATIENT IS INTUBATED, AND A SMALL HOLE IS OBSERVED IN THE LINE THROUGH WHICH BLOOD IS OVERFLOWING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23414310 ↗MalfunctionOct 16, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23313961 ↗MalfunctionOct 6, 2025Retraction Problem; Defective Component; Retraction Problem; Defective Component
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23220639 ↗MalfunctionSep 3, 2025Activation Problem; Activation Problem
NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22951009 ↗MalfunctionSep 3, 2025Activation Problem; Activation Problem
NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22951006 ↗MalfunctionSep 2, 2025Break; Break
IT WAS REPORTED THAT BD SAF-T-INTIMA W/Y ADAPTER BL 22GA X .75IN - TUBING DEFECTIVE/DAMAGED IT WAS REPORTED THAT THE PATIENT WAS PUNCTURED WITH AN INTIMA 22 CATHETER, WHEN CONNECTING THE SERUM TO THE Y, WE OBSERVED THAT THE SILICONE WAS BROKEN NEAR THE CONNECTION OF THE Y, WE REMOVED THE ACCESS, TOOK A NEW INTIMA 22 CATHETER, PUNCTURED THE PATIENT AGAIN, WHEN CONNECTING THE SERUM TO THE Y, WE OBSERVED THAT THE SILICONE WAS BROKEN NEAR THE CONNECTION OF THE Y.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22937324 ↗MalfunctionSep 2, 2025Break; Break
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22937276 ↗MalfunctionAug 26, 2025Material Integrity Problem; Material Integrity Problem
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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22893751 ↗MalfunctionAug 25, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD SAF-T-INTIMA W/Y ADAPTER BL 22GA X .75IN - LEAKAGE. IT WAS REPORTED THAT WITH A CERTAIN FREQUENCY THAT THE INTIMA RUBBER HAS BROKEN WHEN THE CONTRAST IS INJECTED INTO THE INFUSION PUMP, WHICH IS IN THE OTHER PATHWAY WHERE THE CLAVE IS LOCATED. THE PATIENT'S CASE WAS REPORTED TODAY BUT REMEMBER THAT IT WASN'T THE FIRST TIME. CUSTOMER REPORTS LEAKING INTIMA RUBBER AT THE TIME OF CONTRAST INFUSION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22888677 ↗MalfunctionAug 19, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT BD SAF-T-INTIMA W/Y ADAPTER BL 22GA X .75IN TUBING WAS DEFECTIVE/DAMAGED IT WAS REPORTED THAT "HOLE IN THE ESXTENSION OF THE DEVICE, THE LEAKING OCCURRED WHEN THE CATETER WAS INSTALLED, ON THE RETURN THERE WAS ALREADY A LEAK, LOT NUMBER 4081414, PRODUCT PURCHASED FROM THE MANUFACTURER ITSELF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22842309 ↗MalfunctionAug 18, 2025Material Puncture/Hole; Defective Component; Material Puncture/Hole; Defective Component
NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22829859 ↗MalfunctionAug 18, 2025Activation Problem; Activation Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22829092 ↗MalfunctionAug 1, 2025Activation Problem; Activation Problem
NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22689076 ↗MalfunctionJun 19, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22293423 ↗MalfunctionMar 10, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMAITON PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21562207 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page