BD Saf-T-Intima 383313Recalls & reported problems
Becton, Dickinson And Company · BD Saf-T-Intima™ Subcutaneous Catheter System Dual 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 appears in 265 adverse event reports, with no deaths and 6 injuries. The reports mostly describe leaks, particles or contamination, breaks and cracks at the Y port, and some needles that did not retract properly. Reports fell to 5 in the last 12 months from 11 in the year before. No recalls name this device.
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
- 262
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 262 adverse event reports that list this exact device (DI 00382903833139), received between Nov 29, 2017 and Apr 1, 2026 — classified as 6 injuries, 256 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (93 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/Splash93
- Device Contamination with Chemical or Other Material51
- Break44
- Material Protrusion/Extrusion15
- Retraction Problem15
- Fluid/Blood Leak12
- Contamination8
- Defective Device7
Patient problems
- No Clinical Signs, Symptoms or Conditions139
- No Known Impact Or Consequence To Patient81
- No Consequences Or Impact To Patient21
- No Information6
- Needle Stick/Puncture5
- No Patient Involvement5
- Exposure to Body Fluids4
- Insufficient Information2
Recent adverse event reports
The 25 most recent of 262 reports, in the reporter's own words as published by the FDA.
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 ↗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 ↗MalfunctionAug 21, 2025Leak/Splash; Material Puncture/Hole; Material Protrusion/Extrusion; Leak/Splash; Material Puncture/Hole; Material Protrusion/Extrusion
NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 22862771 ↗MalfunctionAug 13, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22796208 ↗MalfunctionJul 9, 2025Leak/Splash; Defective Device; Leak/Splash; Defective Device
IT WAS REPORTED THAT BD SAF-T-INTIMA W/Y ADAPTER YEL 24GA X .75I LEAKED. IT WAS REPORTED BY THE CUSTOMER THAT THE Y PORT HAD A CRACK AND THE MEDICATION LEAKED. VERBATIM: PRODUCTCOMPLAINT REF 383313, LOT 4199702, ISSUE: THE Y PORT HAD A CRACK AND THE MEDICATION LEAKED, NON HAZARDOUS MEDICATION. SAMPLE YES KIT IS REQUESTED PT HARM NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22459423 ↗MalfunctionJul 1, 2025Defective Component; Defective Component
IT WAS REPORTED THAT BD SAF-T-INTIMA W/Y ADAPTER YEL 24GA X .75I STYLET DAMAGED / DEFECTIVECOMPLAINT: GUIDE WIRE BROKE DURING PUNCTURE INSIDE THE SILICONE WIRE, PART OF WHICH GOT STUCK INSIDE AND PART OF WHICH WAS REMOVED ADD INFO RECEIVED ON (B)(6) 2025. IS THERE ANY IMPACT ON PATIENTS? IF YES, PLEASE EXPLAIN IN DETAIL? NO. HAS ANVISA BEEN NOTIFIED? IF YES, WHAT WAS THE NOTIFICATION NUMBER? YES, NT141529. COULD YOU PROVIDE THE DATE THE EVENT OCCURRED? (B)(6) 2025. COULD YOU CONFIRM THE QUANTITY AFFECTED? 01. IS THE SAMPLE RELATED TO THIS INCIDENT AVAILABLE FOR ANALYSIS? IF SO, PLEASE ANSWER THE QUESTIONS BELOW. NOT AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22372492 ↗MalfunctionJun 11, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22186310 ↗MalfunctionMay 21, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE BD SAF-T-INTIMA W/Y ADAPTER YEL 24GA X .75I HAD LEAKAGE AT THE ADAPTER TUBING JUNCTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #383313, LOT #4351793. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. USING SAF-T INTIMA SQ INFUSION CATHETER, NOTED AT INITIAL PUSH OF DARZALEX, TUBING LEAKING AT TUBING Y SITE. WRAPPED WITH OPPOSITE TO CONTINUE INFUSION TO CONCLUSION. LOT #: 4351793, REF: 383313.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22066864 ↗MalfunctionApr 23, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD SAF-T-INTIMA W/Y ADAPTER YEL 24GA X .75I LEAKED AT ADAPTER TUBING JUNCTION. IT WAS REPORTED BY CUSTOMER THAT THE CATHETER LEAKING AT THE CONNECTION POINT CIRCLED BELOW. VERBATIM: PLEASE SEE CUSTOMER EMAIL BELOW: WE HAVE HAD 2 SEPARATE INCIDENT REPORTS FROM OUR CUSTOMER ON THE BD SAF-T-INTIMA CLOSED IV SAFETY CATHETER WITH REFERENCE 383313 FROM 2 DIFFERENT SITES. BOTH SITES REPORTED THE CATHETER LEAKING AT THE CONNECTION POINT CIRCLED BELOW. NEITHER OF THESE INCIDENTS RESULTED IN A SERIOUS OR ADVERSE INCIDENT. PLEASE COULD YOU LET ME KNOW IF BD HAS RECEIVED ANY SIMILAR REPORTS OF THESE CATHETERS LEAKING? WHAT COULD BE THE CAUSE BEHIND THIS AND IS THERE ANYTHING THAT WE COULD ADVISE OUR CUSTOMER TO AVOID RECURRENCE?
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21892332 ↗MalfunctionApr 23, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD SAF-T-INTIMA W/Y ADAPTER YEL 24GA X .75I LEAKED AT ADAPTER TUBING JUNCTION IT WAS REPORTED BY CUSTOMER THAT THE CATHETER LEAKING AT THE CONNECTION POINT CIRCLED BELOW. WE HAVE HAD 2 SEPARATE INCIDENT REPORTS FROM OUR CUSTOMER ON THE BD SAF-T-INTIMA CLOSED IV SAFETY CATHETER WITH REFERENCE: (B)(4) FROM 2 DIFFERENT SITES. BOTH SITES REPORTED THE CATHETER LEAKING AT THE CONNECTION POINT CIRCLED BELOW. NEITHER OF THESE INCIDENTS RESULTED IN A SERIOUS OR ADVERSE INCIDENT. PLEASE COULD YOU LET ME KNOW IF BD HAS RECEIVED ANY SIMILAR REPORTS OF THESE CATHETERS LEAKING? WHAT COULD BE THE CAUSE BEHIND THIS AND IS THERE ANYTHING THAT WE COULD ADVISE OUR CUSTOMER TO AVOID RECURRENCE?
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21892329 ↗MalfunctionMar 20, 2025Crack; Crack
IT WAS REPORTED THAT BD SAF-T-INTIMA W/Y ADAPTER YEL 24GA X .75I ADAPTER WAS DEFECTIVE/DAMAGED PRODUCT PRESENTING A CRACK IN ITS CONNECTION, WHICH LED TO THE SPILLAGE OF CHEMOTHERAPY ON THE PATIENT. THIS IS THE SECOND EVENT WITH THE SAME LOT: 2259640, PURCHASED FROM THE COMPANY B&D INVOICE 767211. NOTIVISA: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21654744 ↗MalfunctionFeb 24, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD SAF-T-INTIMA W/Y ADAPTER YEL 24GA X .75I TUBING SEPERATED FROM ADAPTOR / LUER CONNECTOR AND LEAKED SIDE INJECTOR OF CATHETER DISCONNECTED, CAUSING CHEMOTHERAPY SPILLAGE. QUANTITY: 01 ANVISA NOTIFICATION: NO. SAMPLE AVAILABILITY: NO, PRESENCE OF BIOLOGICAL MATERIAL WAS IT BEING USED ON PATIENT AT THE TIME? YES. WAS PATIENT HARMED? NO. WHEN WAS THE PROBLEM DETECTED? AFTER THE MEDICINE WAS LEAKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21446632 ↗MalfunctionJan 7, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD SAF-T-INTIMA W/Y ADAPTER YEL 24GA X .75I LEAKED AFTER INSERTION OF THE INDWELLING NEEDLE, THE SEALING TUBE WAS FOUND TO HAVE A PRODUCT PROBLEM RESULTING IN LEAKAGE, WHICH WAS REMOVED AND A NEW SET OF INDWELLING NEEDLE WAS INSERTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21095141 ↗MalfunctionOct 9, 2024Defective Component; Defective Component
NO ADDITIONAL INFORMAITON RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20408237 ↗MalfunctionSep 17, 2024Material Protrusion/Extrusion; Material Protrusion/Extrusion
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20237794 ↗MalfunctionSep 9, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT BD SAF-T-INTIMA W/Y ADAPTER YEL 24GA X .75I HAD FOREIGN MATTER FOUND LINT ON THE TIP OF AN INDWELLING NEEDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20169752 ↗MalfunctionAug 22, 2024Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20031417 ↗MalfunctionJun 25, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD SAF-T-INTIMA W/Y ADAPTER YEL 24GA X .75I CATHETER DEFECTIVE / DAMAGED AND LEAKED THE PATIENT WAS GIVEN VENOUS ACCESS, THE PUNCTURE WAS SUCCESSFUL AND BLOOD RETURN WAS SEEN, AND THE BLOOD SEEPAGE FROM THE FLEXIBLE TUBE AT THE END OF THE INDWELLING NEEDLE WAS SEEN WHEN THE NEEDLE CORE WAS NOT WITHDRAWN, AND THE INDWELLING NEEDLE WAS REPLACED AND REINSERTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19606744 ↗MalfunctionJun 20, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD SAF-T-INTIMA W/Y ADAPTER YEL 24GA X .75I LEAKED REPORTED BY NURSE, LEAKAGE OCCURRED DURING USE, NUMBER OF UNITS AFFECTED 1, SAMPLE COULD NOT BE RETURNED, PHOTOS AVAILABLE, GREEN CLAIM REQUIRED, COMPLAINT RESPONSE LETTER AND COMPLAINT RECEIPT LETTER REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19574944 ↗MalfunctionJun 12, 2024Contamination; Contamination
IT WAS REPORTED THAT BD SAF-T-INTIMA W/Y ADAPTER YEL 24GA X .75I HAD FOREIGN MATTER WHEN THE PATIENT WAS GIVEN AN INDWELLING NEEDLE FOR PUNCTURE, A FOREIGN BODY (HAIR) WAS FOUND AT THE NEEDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19521828 ↗MalfunctionJun 11, 2024Defective Component; Defective Component
IT WAS REPORTED THE BD SAF-T-INTIMA W/Y ADAPTER YEL 24GA X .75I CATHETER DEFECTIVE / DAMAGED. IT WAS REPORTED BY CUSTOMER THAT THE SAF T INTIMA HAS HAD 5-6 CATH SPLIT. RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. XX AND OUR INFUSION TEAM HAS BROUGHT IT TO MY ATTENTION THAT THE SAF T INTIMA LOT 3333003 EXP 2027-11-30 (B)(4) HAS HAD 5-6 CATH SPLIT. JUST WONDERING IF YOU HAVE OTHERS MENTION THIS? IT IS VERY UNUSUAL FOR SO MANY IN SAME BOX LOT NUMBER TO BE BAD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19510940 ↗MalfunctionApr 1, 2024Retraction Problem; Material Protrusion/Extrusion; Retraction Problem; Material Protrusion/Extrusion
NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19011512 ↗MalfunctionJan 23, 2024Material Twisted/Bent; Material Twisted/Bent
NO ADDITIONAL INFORMATION WAS PROVIDED ITEM#383313 LOT#3171205.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18567950 ↗MalfunctionDec 29, 2023Contamination; Contamination
IT WAS REPORTED THAT BD SAF-T-INTIMA W/Y ADAPTER YEL 24GA X .75 HAD FOREIGN MATTER THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "1. SPECIFIC OPERATION AND USAGE: THE NURSE IN THE DEPARTMENT OF INFECTIOUS DISEASES AND HEPATOLOGY PREPARED THE PATIENT FOR INTRAVENOUS INDWELLING NEEDLE PUNCTURE. WHEN ADJUSTING THE NEEDLE, IT WAS FOUND THAT THERE WAS FLOC IN THE CATHETER AT THE FRONT OF THE PUNCTURE NEEDLE, WHICH DID NOT AFFECT THE PATIENT. 2. ADVERSE EVENTS: HAIR ON THE NEEDLE OF THE INDWELLING NEEDLE 3. IMPACT ON VICTIMS: PROBLEMS ARE DISCOVERED IN TIME AND ARE NOT USED ON PATIENTS. 4. TREATMENT MEASURES TAKEN AND RESULTS: THE INDWELLING NEEDLE WAS REPLACED AND PUNCTURED AGAIN."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18422085 ↗MalfunctionNov 10, 2023Defective Component; Defective Component
IT WAS REPORTED THAT BD SAF-T-INTIMA W/Y ADAPTER YEL 24GA X .75I NEEDLE WENT THROUGH THE CATHETER THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER; IT WAS REPORTED BY CUSTOMER NOTED THE STYLET PIERCED THROUGH THE PLASTIC CANNULA, CREATING A HOLE IN THE CANNULA. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. NURSE WENT TO PLACE THE IV CATHETER FOR A PATIENT. SHE INSPECTED THE STYLET AT THE END, DID NOT NOTE ANY ISSUES. HOWEVER AS SHE INSERTED IT INTO THE PATIENT, PT SAID IT WAS QUITE PAINFUL, SO SHE REMOVED IT. UPON REMOVAL, SHE NOTED THE STYLET PIERCED THROUGH THE PLASTIC CANNULA, CREATING A HOLE IN THE CANNULA. SHE DISCARDED IV SET.
Patient problems: Insufficient Information
MAUDE report 18112131 ↗
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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.
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