BD Saf-T-Intima 383346Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00382903833467), received between Nov 8, 2017 and Apr 1, 2025 — classified as 2 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (11 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 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 1, 2025Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21748484 ↗
• MalfunctionSep 19, 2024Free or Unrestricted Flow; Free or Unrestricted Flow

  NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20260778 ↗
• MalfunctionSep 19, 2024Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMAITON PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20260320 ↗
• MalfunctionNov 15, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT BD SAF-T-INTIMA W/Y ADAPTER GN 18GA X 1.0IN NEEDLE PULLED OUT OF THE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER; DURING THE PUNCTURE OF A TOMOGRAPHY PATIENT, WHERE HE WAS GOING TO UNDERGO A HEART TOMOGRAPHY, THE METAL PART OF THE NEEDLE CAME OFF, BUT IT WAS POSSIBLE TO REMOVE THE METAL NEEDLE WITHOUT CAUSING HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18144762 ↗
• MalfunctionAug 2, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED WHILE USING BD SAF-T-INTIMA¿ CLOSED IV CATHETER SYSTEM 18 G X 1.00 IN THE STYLET SEPARATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DETAILED DESCRIPTION: WHEN NEEDLE/CATHETER WAS INSERTED INTO THE PATIENT¿S VEIN AND THE NEEDLE WAS ATTEMPTED TO BE REMOVED, THE NEEDLE REMAINED IN THE CATHETER AND IN THE PATIENT¿S VEIN BUT THE SAFETY WIRE WAS REMOVED. IT WAS OBSERVED THAT THE SAFETY WIRE HAD BEEN DETACHED FROM THE NEEDLE LEAVING THE NEEDLE AND CATHETER IN THE PATIENT¿S VEIN. SAMPLE SAVED? YES . BIOHAZARD? YES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17439921 ↗
• MalfunctionNov 30, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED WHILE USING BD SAF-T-INTIMA CLOSED IV CATHETER SYSTEM THE CONNECTION WAS BROKEN. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: THE OPERATING ROOM NURSE REPORTED THAT THE CONNECTION BETWEEN THE TAIL END OF THE INDWELLING NEEDLE AND THE EXTENSION TUBE WAS FOUND TO BE BROKEN DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15888569 ↗
• MalfunctionOct 17, 2022Fluid/Blood Leak

  IT WAS REPORTED THAT THE BD SAF-T-INTIMA¿ SAFETY SYSTEM WITH Y ADAPTER EXPERIENCED LEAKAGE AT THE CATHETER AND HUB JUNCTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE USED THE DEVICE AS A RETURN LINE CATHETER TO A PATIENT DURING A PERIPHERAL ACCESS APHERESIS PROCEDURE. THE FLOW RATE WAS ABOUT 30ML/MIN (WHICH INCLUDES THE ¿RETURN¿ BLOOD FLOW FROM THE APHERESIS MACHINE PLUS A CALCIUM GLUCONATE INFUSION, WHICH WAS CONNECTED TO THE ADDITIONAL PORT ON THE CATHETER). THE ISSUE WAS DISCOVERED WHEN THE PATIENT RAISED HIS ARM TO SHOW THAT THERE WAS BLOOD RUNNING DOWN HIS ARM AND THE DRESSING TO SECURE THE IV SITE WAS SATURATED. THE APHERESIS COLLECTION PROCEDURE WAS PAUSED AND THE SITE WAS UNDRESSED AND CLEANED TO ASSESS WHERE THE BLOOD WAS COMING FROM. THE CATHETER ITSELF WAS IN PLACE AND WAS NOT LEAKING FROM THE VENIPUNCTURE SITE BUT WAS NOTED TRICKLING WHERE THE CATHETER CONNECTS TO THE WINGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15620747 ↗
• MalfunctionNov 19, 2021Retraction Problem; Retraction Problem

  IT WAS REPORTED WHEN USING THE BD SAF-T-INTIMA¿ SAFETY SYSTEM WITH Y ADAPTER THE NEEDLE WAS NOT ABLE TO BE DISENGAGE (REMOVE). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE INDWELLING NEEDLE COULD NOT WITHDRAW THE NEEDLE CORE DURING TRANSFUSION FOR THE PATIENT. THE INDWELLING NEEDLE WAS REPLACED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12846478 ↗
• MalfunctionSep 20, 2021Leak/Splash; Leak/Splash

  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 PRODUCT WAS USED IN THORACIC SURGERY, AND LEAKAGE WAS FOUND IN THE MIDDLE PART OF THE WINGS AFTER PUNCTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12497096 ↗
• MalfunctionSep 13, 2021Leak/Splash; Material Protrusion/Extrusion; Leak/Splash; Material Protrusion/Extrusion

  IT WAS REPORTED WHEN USING THE BD SAF-T-INTIMA¿ SAFETY SYSTEM WITH Y ADAPTER 18 GA 1.00 IN THERE WAS A SAFETY MECHANISM FAILURE AND TUBING CLAMP LOOSE. THIS EVENT OCCURRED 2 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER AND TRANSLATED TO ENGLISH. THE CUSTOMER STATED: "DURING USE, IT WAS FOUND THE INDWELLING NEEDLE WAS STUCK IN THE HEPARIN CAP DUE TO THE JAMMING OF THE SAFETY NEEDLE WITHDRAWING THE NEEDLE.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12465114 ↗
• MalfunctionSep 1, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT THE BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM SEPARATED FROM THE HUB AFTER PLACING IT IN THE EXTERNAL JUGULAR VEIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "THE MOTHER DELIVERED A BABY SAFELY AT 8:00 ON (B)(6) 2021. AT 9:03, DUE TO POSTPARTUM HEMORRHAGE, A SECOND VEIN ACCESS WAS NEEDED TO BE ESTABLISHED, SO THE EXTERNAL JUGULAR VEIN ACCESS WAS OPENED. AFTER SUCCESSFUL CATHETERALIZATION OF THE EXTERNAL JUGULAR INDWELLING NEEDLE, THE EXPOSED PART OF THE TRANSPARENT CATHETER TUBE AND THE GREEN BUTTERFLY PART WERE ACCIDENTALLY SEPARATED DURING THE REMOVAL OF THE NEEDLE." "1. INDWELLING POSITION: LEFT EXTERNAL JUGULAR VEIN. 2. MEASURES: PULL OUT THE PROBLEM CATHETER, REPLACE THE INDWELLING NEEDLE (OTHER BRANDS) AND THE INDWELLING PART (HAND AND FOREARM), AND REINSERT THE CATHETER WITHOUT DELAYING THE TREATMENT. 3. THE WOMAN WAS NOT HARMED AND IS IN GOOD CONDITION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12405216 ↗
• MalfunctionApr 6, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT SAF-T-INTIMA W/Y ADAPTER GN 18GA X 1.0IN HAD FOREIGN MATTER ON THE TIP. THIS OCCURRED ON 5 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER THE NURSE OPENED THE PACKAGE AND REMOVED THE GUARD CAP, IT WAS FOUND THAT THERE WERE UNIDENTIFIED OBJECTS, SIMILAR TO GELATINOUS OBJECTS, ON THE TIP OF ONE CATHETER TUBE AND THE CATHETER TUBE WALL OF TWO INDWELLING NEEDLES. THE CUSTOMER DID NOT USE THE NEEDLE AT LAST AND EXPRESSED DOUBTS ABOUT THE QUALITY CONTROL OF BD. SIMILAR INCIDENTS HAD HAPPENED MANY TIMES BEFORE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11617300 ↗
• MalfunctionFeb 11, 2021Break; Break

  IT WAS REPORTED THAT SAF-T-INTIMA W/Y ADAPTER GN 18GA X 1.0IN NEEDLE WAS BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NURSE WAS PERFORMED PUNCTURING FOR THE PATIENT, DURING PROCESS TO DELIEVE THE NEEDLE, IT WAS FOUND THAT NEEDLE WAS SUDDENLY BROKEN WHEN IT WAS WITHDRAWN WITH 2 MM, THE NURSE HEARD A RELATIVELY CRISP SOUND, CUSTOMER SUSPECTED THAT THERE WAS A PROBLEM WITH THE QUALITY BEFORE THE PUNCTURING.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11312178 ↗
• InjuryJan 13, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT SAF-T-INTIMA W/Y ADAPTER GN 18GA X 1.0IN SAFETY MECHANISM WAS DIFFICULT TO DISENGAGE ON 25 OCCASIONS. THIS CAUSED A NEEDLE STICK INJURY FOR THE NURSE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE INDWELLING NEEDLE WAS ALWAYS PUNCTURED IN THE WARD BEFORE THE SURGERY IN THE HOSPITAL. ON TODAY'S MORNING, WHEN THE NURSE USED 18G PEGASUS TO DO THE PUNCTURING, SHE FOUND THE NEEDLE WAS DIFFICULT TO DISENGAGE AFTER SUCCESSFUL DELIVERING. NURSE DIDN'T WANT TO DO THE PUNCTURING AGAIN SINCE SHE SAW LOTS OF BLOOD IN THE EXTENSION TUBE, SO SHE WANTED TO CLOSE THE CLAMP. WHEN NURSE WAS CLOSING THE CLAMP, SHE WAS INJURED BY THE HALF- WITHDRAWN NEEDLE. PATIENT WAS CONFIRMED WITH HBV, AND NURSE WAS INJECTED THE VACCINE AND WAITING THE EXAMINED REPORT. THE HEAD NURSE AND THE INJURED NURSE WERE ANXIETY, THEY WANTED A FULL RESEARCH AND THE RESULT OF THIS BATCH, AND THEY DIDN'T WANT TO SEE THIS THING AGAIN. SINCE THIS WAS A SERIOUS INCIDENT, IT HAD BEEN REPORTED TO THE EQUIPMENT DEPARTMENT WITH THE NEEDLE STICK INJURY PROCESS.

  Patient problems: Exposure to Body Fluids

  MAUDE report 11168035 ↗
• MalfunctionSep 17, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM TUBING HAD A HOLE IN IT DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "TUBING ATTACHED TO Y ADAPTER HAD A HOLE IN IT, REQUIRING THE IV TO BE REPLACED ".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10551220 ↗
• MalfunctionAug 14, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD SAF-T-INTIMA¿ SAFETY SYSTEM WITH Y ADAPTER 18 GA 1.00 IN LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "AFTER THE SUCCESSFUL USE OF WINMA PUNCTURE IN THE DELIVERY ROOM ON (B)(6), IT WAS FOUND THAT THERE WAS A LEAKAGE AT THE JOINT PART BETWEEN THE EXTENSION TUBE AND THE GREEN Y-SHAPED BASE DURING THE FLUID INFUSION, AND THE INDWELLING NEEDLE WAS IMMEDIATELY REMOVED".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10411619 ↗
• MalfunctionFeb 24, 2020Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM HAD "RESISTANCE" WHEN THE NURSE ATTEMPTED TO PULL BACK THE NEEDLE AFTER USE, UNTIL IT "SNAPPED BACK", PIERCING THROUGH THE SHIELD AND RESULTING IN A DIRTY NEEDLE STICK. BLOOD TESTING WAS DONE ON THE NURSE, AS WELL AS THE SOURCE PATIENT. LOT# 9057759 WAS REPORTED TO HAVE HAD 1 OCCURRENCES OF THIS EVENT, WHILE AN UNSPECIFIED LOT WAS ALSO REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BASICALLY WHAT HAPPENED IS THE RN STARTED AN IV AND WHEN SHE TRIED TO PULL BACK THE NEEDLE SHE MET RESISTANCE. SHE PULLED HARDER TO GET THE NEEDLE OUT AND WHEN SHE DID IT SNAPPED BACK AND WENT THROUGH THE PLASTIC SHEATH RESULTING IN A NEEDLESTICK." "STAFF MEMBER HAD BLOOD WORK PERFORMED AS A RESULT AND "(AND ALSO SOURCE PATIENT) ."

  Patient problems: Needle Stick/Puncture

  MAUDE report 9746939 ↗
• MalfunctionNov 7, 2019Leak/Splash; Device Contamination with Chemical or Other Material; Leak/Splash; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING INSERTION THE DEVICE WAS UNABLE TO PENETRATE THE VEIN DUE TO A DEFORMITY ON THE CATHETER WITH A BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: ON (B)(6) 2019, DURING PENETRATION, IT'S NOTICED THAT 18G STI UNABLE TO PENETRATE INTO THE VEIN NURSE RETRACTED PARTIAL OF THE CATHETER AND NOTICED THAT THE CATHETER'S EDGE VALGUS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9292977 ↗
• MalfunctionNov 5, 2019Break; Break

  IT HAS BEEN REPORTED THAT ONE BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM 18 G X 1.00 IN. HAS BEEN FOUND WITH THE CANNULA BREAKING OFF DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT'S NOTICED THAT NEEDLE BROKEN DURING NEEDLE RETRACTION 18GA STI WAS REMOVED ONCE THE NEEDLE BROKEN WAS NOTICED , NO FURTHER INJURY CAUSED ON PATIENT; THE END USER CONFIRMED THAT NO IMPROPER OPERATION EXIST.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9280066 ↗
• MalfunctionOct 28, 2019Leak/Splash; Device Contamination with Chemical or Other Material; Leak/Splash; Device Contamination with Chemical or Other Material

  MATERIAL NO.: 383346, BATCH NO.: UNKNOWN. IT WAS REPORTED THAT DURING USE OF THE BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM THE CATHETER SEPARATED FROM THE INSERTER LEAVING THE WING AND THE CATHETER IN THE PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER:

  Patient problems: No Code Available

  MAUDE report 9246139 ↗
• MalfunctionAug 15, 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 THAT THERE WAS NEEDLE RETRACTION FAILURE AND CATHETER BROKEN DURING RETRACTION. FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: AFTER SUCCESSFUL RETENTION NEEDLE PUNCTURE, THE NEEDLE CORE CAN NOT BE SUCCESSFULLY EVACUATED, THE HOSE IS BROKEN DURING THE REMOVAL OF THE NEEDLE CORE. ASK THE NURSE TO LOOSEN THE NEEDLE CORE BEFORE THE PUNCTURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8896924 ↗
• InjurySep 17, 2018Retraction Problem; Protective Measures Problem

  IT WAS REPORTED THAT A BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM HAD A NEEDLE THAT FAILED TO RETRACT, CAUSING IT TO PUNCTURE THE TUBING AND STICK AN EMPLOYEE. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 7881808 ↗
• MalfunctionJul 19, 2018Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT THE SAFETY MECHANISM ON THE BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM WOULDN¿T ACTIVATE DURING USE. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION NOTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7704433 ↗
• MalfunctionJan 2, 2018Fluid/Blood Leak

  IT WAS REPORTED THAT THE CATHETER ON A BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM LEAKS DURING INSERTION AND WHEN REMOVED. NO INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7156831 ↗
• MalfunctionNov 8, 2017Mechanical Problem; Fail-Safe Problem

  IT WAS REPORTED THAT THE SAFETY ON A 18 G X 1.00 IN. BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM DID NOT ACTIVATE DURING USE. NO INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7012134 ↗