BD Saf-T-Intima 383335Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00382903833351), received between Dec 29, 2017 and Oct 3, 2024 — classified as 23 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (9 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 3, 2024Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20364091 ↗
• MalfunctionAug 7, 2024Retraction Problem; Material Protrusion/Extrusion; Retraction Problem; Material Protrusion/Extrusion

  IT WAS REPORTED THAT BD UNKNOWN SAF-T-INTIMA DRIP SET WITH SAFETY CATHETER STYLET SEPARATED FROM NEEDLE HEREBY I WOULD LIKE TO INFORM YOU OF AN INCIDENT THAT TOOK PLACE WITH A PATIENT IN OUR HOME CARE ORGANISATION. IT CONCERNS THE PRODUCT: BD SAF-T-INTIMA DRIP SET WITH SAFETY CATHETER. UNFORTUNATELY, I NO LONGER HAVE THE PACKAGING WITH THE SERIAL NUMBER. INCIDENT DESCRIPTION: AFTER INSERTING THE SUBCUTANEOUS DRIP SET, I WANTED TO REMOVE THE NEEDLE VIA THE SAFETY SYSTEM. WHILE REMOVING THE NEEDLE, THE SYSTEM BROKE IN HALF. THE NEEDLE WAS STILL IN THE END OF THE INFUSION TUBE AND THE THIN IRON WIRE WITH WHITE CAP HAD BROKEN OFF FROM THE NEEDLE AND WAS IN MY HANDS. I DID NOT EXPECT THAT WITH A SAFETY CATHETER INFUSION SET, SOMETHING COULD BREAK OFF, THIS MADE THE PRODUCT UNSAFE AND UNCOMFORTABLE TO WORK WITH AT THIS POINT. I HAD TO REMOVE THE DRIP SET FROM THE PATIENT AND THE PATIENT HAD TO BE RE-PRICKED. UNFORTUNATELY, I CAN NO LONGER DETERMINE THE SERIAL NUMBER, BUT I WOULD LIKE TO PASS ON THIS INCIDENT SO THAT YOU ARE INFORMED. I WOULD LIKE TO HEAR YOUR REACTION AND WHETHER A SIMILAR INCIDENT HAS HAPPENED MORE OFTEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19932831 ↗
• MalfunctionFeb 13, 2024Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18696801 ↗
• MalfunctionJan 3, 2024Break; Break

  NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18436724 ↗
• MalfunctionDec 18, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD SAF-T-INTIMA W/PRN PNK 20GA X 1.0IN LEAKED THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER; NURSE REPORTED THAT BLOOD WAS FOUND SPILLING FROM THE WING OF THE INDWELLING NEEDLE WHILE PUNCTURING A PATIENT, AFTER WITHDRAWING THE CORE, THE WING AND EXTENSION CATHETER CONNECTION WAS FOUND TO BE BROKEN, NUMBER OF UNITS AFFECTED 2, SAMPLES COULD NOT BE RETURNED, PHOTOGRAPHS WERE AVAILABLE, COMPLAINT RESPONSE LETTER REQUIRED, COMPLAINT ACCEPTANCE LETTER REQUIRED, GREEN CLAIM REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18352095 ↗
• MalfunctionOct 25, 2022Material Deformation; Material Deformation

  IT WAS REPORTED A PROTRUDING BULGE WAS FOUND ON THE BD SAF-T-INTIMA¿ SAFETY SYSTEM WITH REMOVABLE PRN BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "WHEN THE ICU DEPARTMENT WAS READY TO USE, IT WAS FOUND THAT THERE WAS A PROTRUDING BULGE ON THE CATHETER."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15667302 ↗
• MalfunctionOct 24, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BD SAF-T-INTIMA¿ SAFETY SYSTEM WITH REMOVABLE PRN EXPERIENCED CATHETER SEPARATION FROM THE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: WHEN MRI WAS DONE IN CT ROOM, WHEN THE PRESSURE VALUE WAS 2, THE SYRINGE WAS SEPARATED FROM THE NEEDLE WING, AND BLOOD FLOWED OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15663926 ↗
• MalfunctionJul 20, 2022Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT 75 BD SAF-T-INTIMA¿ SAFETY SYSTEMS WITH REMOVABLE PRN HAD ISSUES WITH THEIR SAFETY MECHANISMS BEING DIFFICULT TO DETACH DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "THE HEAD NURSE OF RADIOLOGY DEPARTMENT REPORTED THE SAFETY DEVICE WAS DIFFICULT TO DETACH FROM THE PRN DURING PUNCTURE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15070889 ↗
• MalfunctionJul 1, 2022Device Damaged Prior to Use; Tear, Rip or Hole in Device Packaging; Device Damaged Prior to Use; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED WHILE USING BD SAF-T-INTIMA¿ CLOSED IV CATHETER SYSTEM THE STERILITY WAS COMPROMISED AND THE PRODUCT WAS BROKEN. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: THE CHILD NEUROLOGY TEACHER SENT THE PRODUCT TO THE EQUIPMENT DEPARTMENT, AND THE EQUIPMENT DEPARTMENT REPORTED THAT BEFORE OPENING THE PACKAGE OF THE PRODUCT, IT WAS FOUND THAT THE OUTER PACKAGE WAS BURNED BY HIGH TEMPERATURE, RESULTING IN CRACKING OF THE PRODUCT. THE OUTER PACKAGE WAS DEFORMED, AND THE PLASTIC PACKAGING INSIDE WAS MELTED, WHICH WAS NO LONGER STERILE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14893084 ↗
• MalfunctionJul 1, 2022Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT THE OUTER PACKAGING OF THE BD SAF-T-INTIMA¿ SAFETY SYSTEM WITH REMOVABLE PRN WAS BURNED AND MELTED, CRACKING THE PRODUCT AND COMPROMISING THE STERILITY. THIS WAS FOUND WITH 3 CATHETERS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "THE CHILD NEUROLOGY TEACHER SENT THE PRODUCT TO THE EQUIPMENT DEPARTMENT, AND THE EQUIPMENT DEPARTMENT REPORTED THAT BEFORE OPENING THE PACKAGE OF THE PRODUCT, IT WAS FOUND THAT THE OUTER PACKAGE WAS BURNED BY HIGH TEMPERATURE, RESULTING IN CRACKING OF THE PRODUCT. THE OUTER PACKAGE WAS DEFORMED, AND THE PLASTIC PACKAGING INSIDE WAS MELTED, WHICH WAS NO LONGER STERILE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14887801 ↗
• MalfunctionMay 9, 2022Material Perforation; Material Perforation

  IT WAS REPORTED BD SAF-T-INTIMA¿ SAFETY SYSTEM WITH REMOVABLE PRN HAD THE NEEDLE PIERCE THE CATHETER WHILE INTRODUCING THE CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "...THE NURSE ON DUTY PERFORMED INDWELLING NEEDLE PUNCTURE WHEN GIVING INFUSION TREATMENT TO THE PATIENT. THE NEEDLE TIP WAS FOUND TO HAVE ENTERED THE SKIN AND THE CATHETER TUBE WAS BLOCKED OUT OF THE SKIN, RESULTING IN PUNCTURE FAILURE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14341795 ↗
• MalfunctionSep 3, 2021Leak/Splash; Device Contamination with Chemical or Other Material; Leak/Splash; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE BD SAF-T-INTIMA¿ SAFETY SYSTEM WITH REMOVABLE PRN BROKE AT THE ROOT OF THE EXTENSION TUBING DURING USE WHILE WITHDRAWING THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "THE NURSE WAS PREPARING TO PERFORM A VENIPUNCTURE ON THE PATIENT. THE ROOT OF THE EXTENSION TUBE BROKE AND BLOOD WAS EXPOSED DURING THE WITHDRAWAL THE NEEDLE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12421951 ↗
• MalfunctionAug 17, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CONNECTION BETWEEN THE FLEXIBLE CATHETER AND THE CATHETER SEAT EXTENDING FROM THE OPAQUE NEEDLE WING IS BLEEDING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12334557 ↗
• MalfunctionJul 30, 2020Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT THE BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM EXPERIENCED DIFFICULT SAFETY MECHANISM/NEEDLE DISENGAGEMENT (REMOVAL) DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ACCORDING TO THE NURSE'S FEEDBACK FROM THE CT ROOM, WHEN THE GUIDE WIRE(NEEDLE) WAS GOING TO PULL OUT AFTER SUCCESSFUL PUNCTURING, IT WAS FOUND THAT THE WIRE COULD NOT BE COMPLETELY DISENGAGED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10348191 ↗
• MalfunctionJan 27, 2020Leak/Splash; Difficult or Delayed Activation; Device Contamination with Chemical or Other Material; Leak/Splash; Difficult or Delayed Activation; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT AFTER THE BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM WAS INSERTED INTO THE LEFT SIDE OF THE PATIENT'S ABDOMEN, THE GUIDE NEEDLE WAS WITHDRAWN. HOWEVER, THE INFUSION TUBING "FAILED" WHERE THE BASE OF THE NEEDLE SAT WITHIN IT, LEAVING BEHIND THE CANNULA, BUTTERFLY, AND SECTION OF TUBING WHEN IT WAS WITHDRAWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NURSE HAD INSERTED BD SAF-T-INTIMA BUTTERFLY TO LEFT ABDOMEN OF PATIENT AND WENT TO WITHDRAW INSERTION GUIDE NEEDLE. DEVICE INFUSION TUBING FAILED AT POINT WHERE BASE OF INSERTION GUIDE NEEDLE SITS WITHIN TUBING LEAVING BEHIND CANNULA, BUTTERFLY AND SMALL SECTION OF TUBING ONCE NEEDLE WAS WITHDRAWN. THIS MEANT THAT DEVICE WAS UNSERVICEABLE AND HAD TO BE REMOVED RESULTING IN THE NEED TO MAKE A SECOND INSERTION WITH A COMPLETELY NEW DEVICE."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9634248 ↗
• MalfunctionJan 6, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT NEEDLE CAP BREAKAGE OCCURRED DURING USE WITH A BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "THE NEEDLE CAP BREAKS OPEN WHEN THE HIGH PRESSURE NEEDLE WAS USED."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9555189 ↗
• MalfunctionJul 31, 2019Leak/Splash; Device Contamination with Chemical or Other Material; Material Protrusion/Extrusion; Leak/Splash; Device Contamination with Chemical or Other Material; Material Protrusion/Extrusion

  IT WAS REPORTED THAT DURING USE OF THE BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM WITH PRN ADAPTER 20 G X 1.00 IN. THE EXTENSION TUBING DETACHED FROM THE NEEDLE WING HUB WHEN NEEDLE RETRACTION DURING THE PENETRATION PROCESS. THIS RESULTED IN BLOOD EXCESS FROM THE NEEDLE WING HUB. FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: IT'S NOTICED THAT EXT. TUBING DETACHED FROM THE NEEDLE WING HUB WHEN NEEDLE RETRACTION DURING THE PENETRATION PROCESS WHICH RESULT IN BLOOD EXCESS FROM THE NEEDLE WING HUB. DETAILED LEAKAGE BLOOD WAITING FOR FURTHER CONFIRMATION. NO BLOOD OR BODILY FLUIDS EXPOSED TO THE NURSE.

  Patient problems: Blood Loss

  MAUDE report 8847074 ↗
• MalfunctionApr 9, 2019Break; Fluid/Blood Leak

  IT WAS REPORTED THAT THE BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM WITH PRN ADAPTER 20 G X 1.00 IN. EXPERIENCED BREAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE EXTENSION TUBING WAS BROKEN AND LEAKED WHEN UNCLAMPED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8496795 ↗
• MalfunctionFeb 6, 2019Positioning Problem

  IT WAS REPORTED THAT THE BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM'S EXTENSION TUBING WAS "OFF FROM WING" DURING USE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8311324 ↗
• MalfunctionJun 14, 2018Fluid/Blood Leak

  IT WAS REPORTED THAT THE NURSE FOUND BLOOD LEAKING AT THE E-TUBING SITE, NEAR THE PRN ROOT USING THE BD SAF-T-INTIMA¿ INTEGRATED SAFETY CATHETER SYSTEM, REMOVABLE PRN ADAPTER. FOUND DURING USE. NO REPORTS OF SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7602215 ↗
• MalfunctionApr 23, 2018Hole In Material; Leak/Splash

  IT WAS REPORTED WITH THE USE OF THE BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM THERE WAS AN ISSUE WITH LEAKAGE. THE CUSTOMER STATED ¿THERE WAS A HOLE FOUND ON THE TUBING WHICH WAS CAUSING SALINE AND BLOOD TO LEAK OUT. HAD TO RE-STICK THE PATIENT DUE TO THE ISSUE WITH THE PRODUCT.¿ THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7451459 ↗
• MalfunctionApr 19, 2018Fluid/Blood Leak; Hole In Material

  IT WAS REPORTED WITH THE USE OF THE BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM THERE WAS AN ISSUE WITH DAMAGED TUBING RESULTING IN LEAKAGE. IT WAS STATED BY THE CUSTOMER ¿THERE WAS A HOLE IN THE TUBING AND BLOOD HAD LEAKED DURING USE. THERE WAS ANOTHER PRODUCT THAT WAS OBSERVED BEFORE USE AND A HOLE WAS IDENTIFIED. THERE WAS NO INJURY TO THE PATIENT. THERE WAS NO EXPOSURE TO BLOOD.¿ THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7444549 ↗
• MalfunctionDec 29, 2017Leak/Splash

  IT WAS REPORTED THAT A NURSE RECALLED ON 3 OCCASIONS WHERE LEAKING OCCURRED ON BD SAF-T-INTIMA¿ INTEGRATED SAFETY CATHETER SYSTEM E-TUBING ADAPTERS WHEN CONNECTED WITH HIGH PRESSURE INFUSION DEVICES. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7154807 ↗