BD Saf-T-Intima 383322Recalls & reported problems

Summary

The FDA's MAUDE database contains 72 adverse event reports that list this exact device (DI 00382903833221), received between Oct 17, 2017 and Mar 21, 2025 — classified as 4 injuries, 68 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (23 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 72 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 21, 2025Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21663961 ↗
• MalfunctionMar 7, 2025Material Separation; Material Separation

  NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21549196 ↗
• MalfunctionJan 6, 2025Material Puncture/Hole; Material Puncture/Hole

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21079948 ↗
• MalfunctionFeb 27, 2024Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18794663 ↗
• MalfunctionFeb 2, 2024Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18631794 ↗
• MalfunctionNov 22, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  NO ADDITIONAL INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18196450 ↗
• MalfunctionNov 9, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BD SAF-T-INTIMA W/PRN BL 22GA X .75IN HAD FOREIGN MATTER THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER; ON (B)(6) 2023 THE GYNECOLOGY NURSE OPENED THE PACKAGE OF THE INDWELLING NEEDLE PRIOR TO PERFORMING A PUNCTURE ON A PATIENT AND FOUND A FOREIGN BODY IN THE CATHETER, WHICH HAS OCCURRED SEVERAL TIMES RECENTLY, RESULTING IN THE NEED TO RE-DISCONNECT THE NEEDLE AND INCREASING THE COST OF THE UNIT, AND THE CHIEF NURSING OFFICER HAS SERIOUS SUSPICIONS ABOUT THE QUALITY AND SAFETY OF THE INDWELLING NEEDLE, AND WOULD LIKE TO FIND OUT WHAT THE CAUSE OF THE FOREIGN BODY IS AND TO PROVIDE AN ANSWER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18107284 ↗
• MalfunctionNov 9, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  NO ADDITIONAL INFORMATION WAS PROVIDED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18107189 ↗
• MalfunctionOct 9, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM HAD FOREIGN MATTER INSIDE IT. THIS OCCURRED WITH 20 CATHETERS. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "ON (B)(6) 2023, THE GYNECOLOGICAL NURSE OPENED THE INDWELLING NEEDLE PACKAGE BEFORE PERFORMING A PUNCTURE ON THE PATIENT AND FOUND A FOREIGN BODY IN THE CATHETER. IT HAS OCCURRED MANY TIMES RECENTLY, RESULTING IN THE NEED TO REMOVE THE NEEDLE AGAIN AND INCREASING THE COST OF THE DEPARTMENT. THE HEAD NURSE SERIOUSLY DOUBTED THE QUALITY AND SAFETY OF THE INDWELLING NEEDLE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17895558 ↗
• MalfunctionOct 4, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED WHILE USING BD SAF-T-INTIMA¿ SAFETY SYSTEM WITH REMOVABLE PRN FOREIGN MATTER WAS FOUND. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: 1. SPECIFIC OPERATION AND USAGE: WHEN THE NURSE IN THE THYROID AND BREAST SURGERY WARD PLACED AN INTRAVENOUS INDWELLING NEEDLE ON THE PATIENT, HE FOUND SUSPICIOUS FLOC ON THE TIP OF THE INDWELLING NEEDLE. 2. ADVERSE EVENTS: THERE IS FOREIGN MATTER IN THE NEEDLE OF THE INDWELLING NEEDLE AND CANNOT BE USED. 3. IMPACT ON VICTIMS: IT HAS NOT BEEN USED ON PATIENTS AND HAS NO IMPACT. 4. TREATMENT MEASURES TAKEN AND RESULTS: IMMEDIATELY REPLACE THE INDWELLING NEEDLE AND CAREFULLY CHECK WHETHER THE INDWELLING NEEDLE IS INTACT BEFORE EACH OPERATION TO AVOID HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17872893 ↗
• MalfunctionSep 29, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM HAD FOREIGN MATTER INSIDE IT. THIS OCCURRED WITH 20 CATHETERS. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "ON SEPTEMBER 13, 2023, THE GYNECOLOGICAL NURSE OPENED THE INDWELLING NEEDLE PACKAGE BEFORE PERFORMING A PUNCTURE ON THE PATIENT AND FOUND A FOREIGN BODY IN THE CATHETER. IT HAS OCCURRED MANY TIMES RECENTLY, RESULTING IN THE NEED TO REMOVE THE NEEDLE AGAIN AND INCREASING THE COST OF THE DEPARTMENT. THE HEAD NURSE SERIOUSLY DOUBTED THE QUALITY AND SAFETY OF THE INDWELLING NEEDLE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17848255 ↗
• MalfunctionSep 6, 2023Contamination; Contamination

  IT WAS REPORTED THAT THE BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM EXPERIENCED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: (B)(6) 2023 WHEN THE NURSE WAS ABOUT TO INJECT THE INDWELLING NEEDLE FOR THE PATIENT, SHE FOUND THAT THERE WAS HAIRY MATTER INSIDE THE PACKAGE, AND THE NEEDLE WAS CONTAMINATED AND COULD NOT BE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17691025 ↗
• InjuryAug 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT EXTRAVASATION OCCURRED WITH THE BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM DURING USE, CAUSING SWELLING AT THE INJECTION SITE. NO FURTHER INFORMATION WAS PROVIDED. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 3 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER HAS RECEIVED DEFECTIVE PRODUCT THAT DIDN'T WORK WITH THE PATIENT & GIVE THE RESULTS AS IT SHOULD. THEY COMPARED IT WITH ANOTHER LOT NUMBER THEY HAD & IT WORKED FOR THE PATIENTS & GAVE THE CORRECT RESULTS. THEY HAVE ONLY OPENED 1 BX, 6 EA LEFT, AND 3 BX ARE IN THE ORIGINAL PACKAGING & UNOPENED. ADDITIONAL INFO FROM CUSTOMER: ON (B)(6) 2023). CAN YOU DESCRIBE MORE ON THE DEFECTS FOUND ON THE PRODUCT? MULTIPLE IV¿S INFILTRATED WITH THIS CATHETER LOT# AND HAVE BEEN VERY FEW PREVIOUSLY. IV¿S WERE DONE WITH OTHER PRODUCT, AND EXAM COMPLETED WITHOUT INFILTRATION. IS THERE ANY ADVERSE EVENT OR SERIOUS INJURY HAPPENED? PATIENTS HAD SWOLLEN INJECTION SITES AS IT DOES WITH INFILTRATION, AND PATIENT COMPLAINTS. 1. WHAT IS THE OCCURRENCE NUMBER? TO MY KNOWLEDGE, NO VISIBLE DEFECT IN THE CATHETER ITSELF AS FAR AS THE MATERIALS/APPEARANCE. 2. WHILE USING THE CATHETERS FROM

  Patient problems: Extravasation

  MAUDE report 17628574 ↗
• InjuryAug 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT EXTRAVASATION OCCURRED WITH THE BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM DURING USE, CAUSING SWELLING AT THE INJECTION SITE. NO FURTHER INFORMATION WAS PROVIDED. THIS COMPLAINT WAS CREATED TO CAPTURE THE 3RD OF 3 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER HAS RECEIVED DEFECTIVE PRODUCT THAT DIDN'T WORK WITH THE PATIENT & GIVE THE RESULTS AS IT SHOULD. THEY COMPARED IT WITH ANOTHER LOT NUMBER THEY HAD & IT WORKED FOR THE PATIENTS & GAVE THE CORRECT RESULTS. THEY HAVE ONLY OPENED 1 BX, 6 EA LEFT, AND 3 BX ARE IN THE ORIGINAL PACKAGING & UNOPENED... ADDITIONAL INFO FROM CUSTOMER: (17-AUG-2023) CAN YOU DESCRIBE MORE ON THE DEFECTS FOUND ON THE PRODUCT? MULTIPLE IV¿S INFILTRATED WITH THIS CATHETER LOT # AND HAVE BEEN VERY FEW PREVIOUSLY. IV¿S WERE DONE WITH OTHER PRODUCT, AND EXAM COMPLETED WITHOUT INFILTRATION. IS THERE ANY ADVERSE EVENT OR SERIOUS INJURY HAPPENED? PATIENTS HAD SWOLLEN INJECTION SITES AS IT DOES WITH INFILTRATION, AND PATIENT COMPLAINTS. 1. WHAT IS THE OCCURRENCE NUMBER? TO MY KNOWLEDGE, NO VISIBLE DEFECT IN THE CATHETER ITSELF AS FAR AS THE MATERIALS/APPEARANCE 2. WHILE USING THE CATHETERS FROM T

  Patient problems: Extravasation

  MAUDE report 17628038 ↗
• InjuryAug 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT EXTRAVASATION OCCURRED WITH THE BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM DURING USE, CAUSING SWELLING AT THE INJECTION SITE. NO FURTHER INFORMATION WAS PROVIDED. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 3 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER HAS RECEIVED DEFECTIVE PRODUCT THAT DIDN'T WORK WITH THE PATIENT & GIVE THE RESULTS AS IT SHOULD. THEY COMPARED IT WITH ANOTHER LOT NUMBER THEY HAD & IT WORKED FOR THE PATIENTS & GAVE THE CORRECT RESULTS. THEY HAVE ONLY OPENED 1 BX, 6 EA LEFT, AND 3 BX ARE IN THE ORIGINAL PACKAGING & UNOPENED... ADDITIONAL INFO FROM CUSTOMER: (17-AUG-2023) CAN YOU DESCRIBE MORE ON THE DEFECTS FOUND ON THE PRODUCT? MULTIPLE IV¿S INFILTRATED WITH THIS CATHETER LOT # AND HAVE BEEN VERY FEW PREVIOUSLY. IV¿S WERE DONE WITH OTHER PRODUCT, AND EXAM COMPLETED WITHOUT INFILTRATION. IS THERE ANY ADVERSE EVENT OR SERIOUS INJURY HAPPENED? PATIENTS HAD SWOLLEN INJECTION SITES AS IT DOES WITH INFILTRATION, AND PATIENT COMPLAINTS. 1. WHAT IS THE OCCURRENCE NUMBER? TO MY KNOWLEDGE, NO VISIBLE DEFECT IN THE CATHETER ITSELF AS FAR AS THE MATERIALS/APPEARANCE. 2. WHILE USING THE CATHETERS FROM

  Patient problems: Extravasation

  MAUDE report 17627438 ↗
• MalfunctionAug 9, 2023Contamination; Contamination

  IT WAS REPORTED THAT WHITE FOREIGN MATTER WAS FOUND ON THE TIP OF THE BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM NEEDLE BEFORE PLACING IT IN THE PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "ON (B)(6) 2023, WHEN THE MEDICAL STAFF WAS ABOUT TO PLACE AN INDWELLING NEEDLE FOR THE PATIENT, THEY FOUND THAT THERE WAS A WHITE UNIDENTIFIED FLOC ON THE TIP OF THE NEEDLE, WHICH COULD NOT BE USED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17492125 ↗
• MalfunctionJul 20, 2023Break; Break

  IT WAS REPORTED THAT WHILE USING THE BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM THE TUBE WAS BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: AT 10 A.M. ON (B)(6)2023, THE PATIENT SUSPENDED THE INTRAVENOUS INFUSION BECAUSE OF GOING OUT FOR INSPECTION, AND SEALED THE TUBE WITH A NEWLY INDWELLING TROCAR. THE PATIENT RETURNED TO THE WARD AFTER THE EXAMINATION. WHEN THE SMALL WHITE CLIP WAS OPENED, THE TUBE UNDER THE TROCAR NEEDLE WING BROKE, AND THERE WAS A QUALITY PROBLEM, WHICH WAS REPORTED TO THE HEAD NURSE. THE TROCAR WAS REPLACED FOR THE PATIENT, AND THE INTRAVENOUS INFUSION WENT SMOOTHLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17358168 ↗
• MalfunctionApr 13, 2023Crack; Leak/Splash; Crack; Leak/Splash

  IT WAS REPORTED THAT THE BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM EXPERIENCED A CRACK CAUSING LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: ON (B)(6) 2023, WHEN THE NURSES OF THE GENERAL DEPARTMENT PERFORMED THE OPERATION AND TREATMENT OF THE PATIENT'S INTRAVENOUS INDWELLING NEEDLE, THE OPERATION PROCESS WAS SMOOTH, AND THE NEEDLE CORE WAS WITHDRAWN IN ONE STEP, AND THERE WAS NO PROCESS OF THE NEEDLE TIP STAYING IN THE HOSE. WHEN THE INDWELLING TUBE WAS FLUSHED AFTER INDWELLING, IT WAS FOUND THAT THE END OF THE INDWELLING TUBE LEAKED. AFTER CAREFUL INSPECTION, A CRACK WAS FOUND IN THE TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16740470 ↗
• MalfunctionMar 29, 2023Crack; Leak/Splash; Crack; Leak/Splash

  IT WAS REPORTED THAT A CRACK IN THE BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM EXTENSION TUBING CAUSED FLUID TO LEAK OUT DURING USE. THIS OCCURRED WITH 5 CATHETERS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "ON (B)(6) 2023, AFTER THE INDWELLING NEEDLE WAS PUNCTURED FOR THE PATIENT, THE NURSE IN THE BURN DEPARTMENT FOUND THAT THERE WAS A CRACK IN THE EXTENSION TUBE, WHICH LED TO FLUID LEAKAGE. THIS HAS HAPPENED MANY TIMES RECENTLY, RESULTING IN THE NEED FOR RE-PUNCTURE. THE PATIENT WAS VERY DISSATISFIED, AND THE HEAD NURSE HOPED TO AVOID THIS SITUATION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16637545 ↗
• MalfunctionMar 13, 2023Contamination; Contamination

  IT WAS REPORTED THAT WHITE FOREIGN MATTER WAS FOUND ON THE BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM NEEDLE AFTER REMOVING IT FROM THE PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "WHEN PREPARING TO INDWELL THE PATIENT. WHEN UNPACKING, IT WAS FOUND THAT THERE WERE WHITE FLOC ON THE NEEDLE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16533616 ↗
• MalfunctionDec 21, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM NEEDLE HAD BLACK THREAD AROUND IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "(B)(6) 2022, WHEN THE INDWELLING NEEDLE WAS TORN APART, TWO BLACK THIN THREADS WERE FOUND TO BE WRAPPED AROUND THE INDWELLING NEEDLE TIP, STOP USING IT IMMEDIATELY, AND REPORT TO THE NURSE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16030196 ↗
• MalfunctionAug 24, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM NEEDLE PIERCED THROUGH THE CATHETER TUBE AFTER INSERTING IT INTO THE VEIN AND REMOVING THE GUIDEWIRE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "WHEN THE GUIDE WIRE WAS WITHDRAWN, THE NEEDLE TIP PUNCTURED THROUGH THE EXTENSION TUBE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15286212 ↗
• MalfunctionJul 18, 2022Contamination; Contamination

  IT WAS REPORTED THAT FOREIGN, MUCUS-LIKE MATTER WAS FOUND ON THE CATHETER TIP OF THE BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "THE CATHETER TIP WAS FOUND WITH MUCUS WHEN THE INDWELLING NEEDLE WAS REMOVED FOR USE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15048017 ↗
• MalfunctionJul 16, 2022Contamination; Contamination

  IT WAS REPORTED THAT PRIOR TO USE WITH BD SAF-T-INTIMA¿ SAFETY SYSTEM WITH REMOVABLE PRN 22 GA 0.75 IN A FOREIGN BODY IN THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: WHEN THE NURSE OPENED THE PACKAGE, SHE FOUND A FOREIGN BODY IN THE NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15035133 ↗
• MalfunctionJun 13, 2022Break; Break

  IT WAS REPORTED WHILE USING BD SAF-T-INTIMA¿ SAFETY SYSTEM WITH REMOVABLE PRN THE CLIP WAS BROKEN. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6), WHEN THE NURSE CONNECTED THE VENOUS INDWELLING NEEDLE WITH INFUSION FOR THE PATIENT, IT WAS FOUND THAT THE SMALL CLIP OF THE CONNECTING TUBE OF THE VENOUS INDWELLING NEEDLE PLACED THE DAY BEFORE WAS BROKEN, AND THE VENOUS INDWELLING NEEDLE WAS IMMEDIATELY REMOVED AND RE-PUNCTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14674502 ↗