BD Saf-T-IntimaRecalls & reported problems across all models
Becton, Dickinson And Company · 7 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 863
- Deaths reported
- 0
- Injuries reported
- 33
- Recalls
- 0
We found 7 models of BD Saf-T-Intima by Becton, Dickinson And Company in the FDA's device registry (GUDID). Together they are named in 863 adverse event reports in the FDA's MAUDE database, received between Oct 17, 2017 and Jun 22, 2026 — classified as 33 injuries, 830 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (299 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported BD Saf-T-Intima problems
Device problems
- Leak/Splash299
- Device Contamination with Chemical or Other Material160
- Break116
- Material Protrusion/Extrusion52
- Fluid/Blood Leak46
- Retraction Problem44
- Contamination24
- Material Puncture/Hole24
Patient problems
- No Clinical Signs, Symptoms or Conditions460
- No Known Impact Or Consequence To Patient246
- No Consequences Or Impact To Patient76
- Needle Stick/Puncture25
- No Information17
- No Patient Involvement12
- Exposure to Body Fluids10
- Insufficient Information6
BD Saf-T-Intima models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- BD Saf-T-Intima 383313Catheter,intravascular,therapeutic,short-term less than 30 days262 reports
- BD Saf-T-Intima 383323Catheter,intravascular,therapeutic,short-term less than 30 days256 reports
- BD Saf-T-Intima 383312Catheter,intravascular,therapeutic,short-term less than 30 days154 reports
- BD Saf-T-Intima 383322Catheter,intravascular,therapeutic,short-term less than 30 days72 reports
- BD Saf-T-Intima 383336Catheter,intravascular,therapeutic,short-term less than 30 days71 reports
- BD Saf-T-Intima 383346Catheter,intravascular,therapeutic,short-term less than 30 days25 reports
- BD Saf-T-Intima 383335Catheter,intravascular,therapeutic,short-term less than 30 days23 reports
Recent BD Saf-T-Intima adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionApr 1, 2026Retraction Problem
IT WAS REPORTED THAT WHILE ADMINISTERING AN IV TO A PATIENT, THE NEEDLE DID NOT COME OUT COMPLETELY WHEN IT WAS REMOVED, LEAVING IT EXPOSED. THE NURSE REALIZED THERE HAD BEEN NO SHARPS INJURY AND DISPOSED OF THE NEEDLE. THIS INCIDENT OCCURRED IN (B)(6) 2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24754181 ↗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 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 ↗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 18, 2025Material Puncture/Hole; Material Protrusion/Extrusion; Material Puncture/Hole; Material Protrusion/Extrusion
WHEN PUNCTURING THE CHILD, THE NEEDLE DISLODGED, PIERCING THE FLEXIBLE TUBE CATHETER AND WRINKLING THE TUBE, CAUSING PAIN TO THE PATIENT, REQUIRING A NEW PUNCTURE TO BE PERFORMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23583235 ↗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 ↗
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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