BD Saf-T-Intima 383312Recalls & reported problems
Becton, Dickinson And Company · BD Saf-T-Intima™ Subcutaneous Catheter System Single Port 24 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 catheter is a short-term catheter used to deliver fluids or medicine into the body. Its 154 reports mostly describe fluid leaking from the device, foreign material found on it, and parts breaking or separating from the hub. The reports include no deaths and 7 injuries, and 147 are malfunctions. No recalls name this device. Reports dropped from 3 in the year before to none in the latest year.
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
- 154
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 154 adverse event reports that list this exact device (DI 00382903833122), received between Dec 4, 2017 and Jun 25, 2025 — classified as 7 injuries, 147 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (53 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/Splash53
- Device Contamination with Chemical or Other Material39
- Break27
- Defective Component8
- Contamination7
- Fluid/Blood Leak5
- Material Protrusion/Extrusion5
- Adverse Event Without Identified Device or Use Problem4
Patient problems
- No Clinical Signs, Symptoms or Conditions85
- No Known Impact Or Consequence To Patient41
- No Consequences Or Impact To Patient14
- Needle Stick/Puncture5
- No Information5
- Unspecified Infection3
- Insufficient Information2
- No Patient Involvement2
Recent adverse event reports
The 25 most recent of 154 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 25, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem
IT WAS REPORTED THAT BD SAF-T-INTIMA W/PRN YEL 24GA X .75IN SAFETY SHIELD ACTIVATION FAILED IT WAS REPORTED BY CUSTOMER THAT THE BACK CHECK VALVE DEFECTIVE ON PRIMARY TUBING. WHEN PATIENT'S IMMUNOTHERAPY DRUG INFUSION WAS UNCLAMPED ON SECONDARY LINE, DRUG FLOWED UP INTO SALINE BAG CONNECTED TO PRIMARY LINE. IMMUNOTHERAPY INFUSION ON SECONDARY LINE WAS HANGING ABOVE SALINE BAG, AND SECONDARY LINE WAS CONNECTED TO PRIMARY LINE'S UPPER Y-SITE. THIS RN NOTICED IMMUNOTHERAPY DRUG WAS FLOWING INTO THE SALINE BAG INSTEAD OF BYPASSING SALINE BAG AND INTO PUMP. PUMP WAS STOPPED, SECONDARY LINE CLAMPED, AND NEW PRIMARY TUBING CONNECTED TO SALINE BAG. VERBATIM: BACK CHECK VALVE DEFECTIVE ON PRIMARY TUBING. WHEN PATIENT'S IMMUNOTHERAPY DRUG INFUSION WAS UNCLAMPED ON SECONDARY LINE, DRUG FLOWED UP INTO SALINE BAG CONNECTED TO PRIMARY LINE. IMMUNOTHERAPY INFUSION ON SECONDARY LINE WAS HANGING ABOVE SALINE BAG, AND SECONDARY LINE WAS CONNECTED TO PRIMARY LINE'S UPPER Y-SITE. THIS RN NOTICED IMMUNOTHERAPY DRUG WAS FLOWING INTO THE SALINE BAG INSTEAD OF BYPASSING SALINE BAG AND INTO PUMP. PUMP WAS STOPPED, SECONDARY LINE CLAMPED, AND NEW PRIMARY TUBING CONNECTED TO SALINE BAG.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22331773 ↗MalfunctionMay 12, 2025Material Integrity Problem; Material Integrity Problem
NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22005774 ↗MalfunctionMay 12, 2025Material Integrity Problem; Material Integrity Problem
NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22005771 ↗MalfunctionSep 17, 2024Defective Component; Defective Component
IT WAS REPORTED THAT BD SAF-T-INTIMA W/PRN YEL 24GA X .75IN CATHETER BROKE / SEPARATED FROM HUB DURING USE, THE FRONT END OF THE AUTOMATIC RETRACTION OF THE NEEDLE TUBE RUPTURE, CAN NOT BE USED, RE-REPLACE THE NEEDLE TO COMPLETE THE SUBSEQUENT OPERATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20238619 ↗MalfunctionJul 25, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT BD SAF-T-INTIMA W/PRN YEL 24GA X .75IN HAD FOREIGN MATTER OPEN THE NEEDLE CAP AND FIND BLACK FLOC ON THE TIP OF THE NEEDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19824507 ↗MalfunctionJun 12, 2024Contamination; Contamination
MalfunctionJun 12, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD SAF-T-INTIMA W/PRN YEL 24GA X .75IN LEAKED AFTER THE INDWELLING NEEDLE WAS INSERTED INTO THE PATIENT ON MAY 9, LEAKAGE WAS FOUND IN THE MIDDLE PART OF THE INDWELLING NEEDLE PIPE WHEN INJECTING NORMAL SALINE. AFTER IMMEDIATE REMOVAL, THE INDWELLING NEEDLE WAS REPLACED AND RE-INJECTED, AND THE PATIENT WAS EXPLAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19520770 ↗MalfunctionMay 3, 2024Material Separation; Material Separation
IT WAS REPORTED THAT THE BD SAF-T-INTIMA W/PRN YEL 24GA X .75IN WINGS WERE DAMAGED/DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM CHINESE TO ENGLISH: WHEN USED IN NEUROSURGERY, THE CONNECTION BETWEEN THE EXTENSION TUBE AND THE NEEDLE WING IS DISCONNECTED AND CANNOT BE RETURNED. THERE ARE PICTURES, A CLAIM IS REQUIRED, A COMPLAINT REPLY LETTER IS REQUIRED, AND A COMPLAINT ACCEPTANCE LETTER IS REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19239643 ↗MalfunctionApr 29, 2024Defective Component; Defective Component
IT WAS REPORTED THAT THE BD SAF-T-INTIMA W/PRN YEL 24GA X .75IN LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM CHINESE TO ENGLISH. "ON (B)(6) WHEN THE CHILD ENTERED THE OPERATING ROOM AND STARTED TO GIVE FLUIDS, IT WAS FOUND THAT THE PIPE AT THE WATER STOP CLAMP OF THE INDWELLING NEEDLE WAS BROKEN AND LEAKING." NO PATIENT HARM REPORTED, PATIENT RE-PUNCTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19203849 ↗MalfunctionApr 15, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
MalfunctionFeb 23, 2024Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18768242 ↗MalfunctionJan 22, 2024Leak/Splash; Defective Component; Leak/Splash; Defective Component
NO ADDITIONAL INFORMATION RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18553227 ↗MalfunctionDec 19, 2023Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18360863 ↗MalfunctionDec 19, 2023Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18360758 ↗MalfunctionDec 12, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD SAF-T-INTIMA W/PRN YEL 24GA X .75IN TUBING WAS DEFECTIVE / DAMAGED THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER; "1. SPECIFIC OPERATIONAL USE: INFECTED HEPATOLOGY WARD ON NOVEMBER 13, ACCORDING TO MEDICAL ADVICE TO THE PATIENT RETAINED PERIPHERAL VENOUS INDWELLING NEEDLE, THE REMAINING NOVEMBER 14, 9:00 A.M. FOUND THAT THE INDWELLING NEEDLE CLAMP BUCKLE CRACKED SEEPAGE. 2. ADVERSE EVENT SITUATION: THE CLIP BUCKLE OF THE INDWELLING NEEDLE CRACKED AND LEAKED FLUID. 3. IMPACT ON THE VICTIM: THE LEAKING FLUID SOAKED THE PATIENT'S GOWN, CAUSING NO HARM TO THE PATIENT. 4. TREATMENT MEASURES TAKEN AND OUTCOME: IMMEDIATELY REPLACE THE INDWELLING NEEDLE WITH A NEW ONE AFTER DISCOVERY AND REPORT THE ADVERSE EVENT".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18314648 ↗MalfunctionNov 22, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT BD SAF-T-INTIMA HAD FOREIGN MATTER. 1. SPECIFIC OPERATION AND USE: THE NURSE OF THE GYNECOLOGY DEPARTMENT CONDUCTS ROUTINE EXAMINATION AND FINDS FOREIGN BODIES BEFORE USING THE INDWELLING NEEDLE ON THE PATIENT. 2. ADVERSE EVENTS: CONTAMINATION OF THE INDWELLING NEEDLE, AND FOREIGN BODIES WERE FOUND IN THE INDWELLING NEEDLE CANNULA. 3. IMPACT ON THE VICTIM: IT WAS FOUND IN TIME THAT IT WAS NOT USED ON THE PATIENT AND DID NOT CAUSE ADVERSE EFFECTS. 4. TREATMENT MEASURES AND RESULTS: IMMEDIATELY REPLACE THE PRODUCT WITH A NEW INDWELLING NEEDLE TO CHECK WHETHER THERE IS ANY FOREIGN BODY, AND REPORT ADVERSE EVENTS TO THE RETAINED DIRT INDWELLING NEEDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18196670 ↗MalfunctionNov 9, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18107119 ↗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 18107049 ↗MalfunctionOct 13, 2023Contamination; Contamination
IT WAS REPORTED WHILE USING BD SAF-T-INTIMA¿ SAFETY SYSTEM WITH REMOVABLE PRN 24 GA 0.75 IN 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: ON SEPTEMBER 22, WHEN THE NURSE IN THE DEPARTMENT OF INFECTIOUS DISEASES AND HEPATOLOGY WAS PREPARING TO PERFORM VENIPUNCTURE ON THE PATIENT, HE FOUND A SMALL AMOUNT OF FOREIGN MATTER AT THE TIP OF THE INTRAVENOUS INDWELLING NEEDLE. 2. ADVERSE EVENTS: THERE IS FOREIGN MATTER IN THE NEEDLE OF THE INDWELLING NEEDLE AND CANNOT BE USED. 3. IMPACT ON VICTIMS: NO USE ON PATIENTS, NO IMPACT 4. TREATMENT MEASURES TAKEN AND RESULTS: REPLACE WITH A NEW INDWELLING NEEDLE AND REPORT TO THE MEDICAL ENGINEERING DEPARTMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17935230 ↗MalfunctionSep 20, 2023Defective Component; Defective Component
IT WAS REPORTED THAT THE BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM NEEDLE WAS DAMAGED. THE FOLLOWING WAS TRANSLATED FROM CHINESE TO ENGLISH: THE NEEDLE CORE OF THE INDWELLING NEEDLE IS DAMAGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17785715 ↗MalfunctionSep 12, 2023Break; Leak/Splash; Break; Leak/Splash
IT WAS REPORTED THAT THE BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM LEAKED BLOOD FROM THE BROKEN EXTENSION TUBING DURING USE. THIS OCCURRED WITH 5 CATHETERS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "THE ENT NURSE PERFORMED AN INDWELLING NEEDLE FOR THE PATIENT ON (B)(6) 2023. AFTER CATHETER MAINTENANCE, HE CLOSED THE TUBE SEALING CLIP AND FOUND THAT THE CATHETER EXTENSION TUBE WAS LEAKING BLOOD. CAREFUL OBSERVATION REVEALED THAT THE EXTENSION TUBE AT THE SEALING CLIP WAS BROKEN. THIS KIND OF SITUATION HAS HAPPENED MANY TIMES."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17733196 ↗MalfunctionAug 7, 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 24 GA 0.75 IN 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: FROM (B)(6)2023, THE MEDICAL STAFF FOUND FLOC IN THE NEEDLE AND REPLACED IT. NOTIFY THE MANUFACTURER TO RECALL AND REPLACE THIS BATCH OF PRODUCTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17477182 ↗MalfunctionAug 7, 2023Break; Break
IT WAS REPORTED WHILE USING BD SAF-T-INTIMA¿ SAFETY SYSTEM WITH REMOVABLE PRN 24 GA 0.75 IN THE TUBING WAS DAMAGED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: ON (B)(6) 11, 2023, THE MEDICAL STAFF FOUND THAT THE INFUSION TUBE OF THE INDWELLING NEEDLE WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17470938 ↗MalfunctionJun 26, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED WHILE USING BD SAF-T-INTIMA¿ SAFETY SYSTEM WITH REMOVABLE PRN 24 GA 0.75 IN LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: ON MAY 19, THE NURSE GAVE THE INPATIENT AN INFUSION, AND THE EXHAUST INSPECTION TUBE WAS NORMAL. AFTER THE PUNCTURE WAS SUCCESSFUL, THE 3M TRANSPARENT APPLICATOR WAS FIXED. ABOUT 30 MINUTES LATER, DURING THE INSPECTION OF THE INFUSION PROCESS, A LITTLE LIQUID WAS FOUND ON THE BACK OF THE PATIENT'S HAND, AND THE PATIENT CAREFULLY OBSERVED THAT THERE WAS LIQUID AT THE PLASTIC HOSE OF THE PATIENT'S INDWELLING NEEDLE. AFTER COMMUNICATING WITH THE PATIENT, IT IS RECOMMENDED TO RE-PUNCTURE. THE PATIENT AND HIS FAMILY MEMBERS REQUIRE THE TAPE TO BE FIXED AFTER DISINFECTION, AND TEMPORARILY RETAIN IT AFTER CHECKING FOR NO BLEEDING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17205250 ↗MalfunctionJun 22, 2023Contamination; Contamination
IT WAS REPORTED THAT 5 OF THE BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM EXPERIENCED FOREIGN MATTER, CONTAMINATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: IN THORACIC SURGERY, WHEN THE PACKAGE WAS OPENED, IT WAS FOUND THAT THERE WAS A FOREIGN OBJECT ON THE NEEDLE TIP, WHICH WAS VERY OBVIOUS LIKE GLUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17181376 ↗
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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