BD Insyte-W 381312Recalls & reported problems
Becton, Dickinson And Company · INSYTE-W WINGED YEL 24GA X 0.75IN · Class 2
All models of BD Insyte-W (8)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This BD Insyte-W winged IV catheter is a short-term catheter used for intravenous therapy. Of the 162 reports, 151 are malfunctions, and many describe saline leaking at the connection, tubing breaking or being damaged, and a cannula sheath that could not be removed. The reports include 1 death and 10 injuries. 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
- 161
- Deaths reported
- 1
- Injuries reported
- 9
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 161 adverse event reports that list this exact device (DI 00382903813124), received between Nov 27, 2017 and Sep 23, 2026 — classified as 1 death, 9 injuries, 151 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (61 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/Splash61
- Device Contamination with Chemical or Other Material31
- Break27
- Defective Component11
- Material Puncture/Hole7
- Material Split, Cut or Torn7
- Adverse Event Without Identified Device or Use Problem5
- Fluid/Blood Leak5
Patient problems
- No Clinical Signs, Symptoms or Conditions76
- No Known Impact Or Consequence To Patient46
- No Consequences Or Impact To Patient12
- No Patient Involvement5
- Extravasation4
- Erythema3
- Insufficient Information3
- Complaint, Ill-Defined2
Recent adverse event reports
The 25 most recent of 161 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 23, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873036 ↗MalfunctionSep 23, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873035 ↗MalfunctionSep 11, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50736902 ↗MalfunctionJun 11, 2026Leak/Splash
THEY TELL US THAT THE CATHETER CONNECTION (THREADED JOINT) DOES NOT SEEM TO BE PROPERLY SECURED AND IS LEAKING SALINE. BATCH: 5337999 OF 1. WE HAVE A CUSTOMER WHO HAS INFORMED US THAT THE LATEST BOX THEY RECEIVED OF INSYTE W ALETAS 24G YELLOW - REF. 381312 IS CAUSING THEM PROBLEMS. THIS CUSTOMER HAS BEEN PURCHASING THE PRODUCT REGULARLY SINCE 2020 AND HAD NEVER COMPLAINED BEFORE. THEY TELL US THAT THE CATHETER CONNECTION (THREAD) DOES NOT SEEM TO FIT PROPERLY AND IS LEAKING SALINE. BATCH: 5337999, DATED 30/11. WHEN DID THE INCIDENT OCCUR? BEFORE USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25473306 ↗MalfunctionMay 29, 2026Material Split, Cut or Torn
AT 9:10 A.M. ON (B)(6) 2026, WHILE PERFORMING AN INTRAVENOUS PUNCTURE ON A PATIENT, THE NEEDLE CONE DAMAGED THE TUBING AS SOON AS THE CANNULA ENTERED THE VEIN, MAKING IT IMPOSSIBLE TO ADVANCE THE CATHETER INTO THE VEIN. THE EQUIPMENT WAS REPLACED IMMEDIATELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25334274 ↗MalfunctionMay 21, 2026Nonstandard Device
(B)(6) 2026: WHILE INSERTING AN IV CANNULA INTO A PATIENT, A NURSE DISCOVERED THAT THE CANNULA SHEATH COULD NOT BE REMOVED. THE CANNULA WAS REPLACED, AND THE ADVERSE EVENT WAS DOCUMENTED AND REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25243839 ↗MalfunctionMay 12, 2026Nonstandard Device
NURSE REPORTED TUBING BREAKAGE DURING USE, NUMBER OF UNITS AFFECTED 10, PHYSICAL DEVICE CAN BE RETURNED 1, PHOTOGRAPHS AVAILABLE, GREEN CLAIM REQUIRED, COMPLAINT RETURN LETTER REQUIRED, COMPLAINT RECEIPT LETTER REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25150367 ↗MalfunctionMay 1, 2026Fluid/Blood Leak
DURING USE, FLUID LEAKED FROM THE CONNECTION BETWEEN THE CATHETER AND THE CATHETER ADAPTER. ONE UNIT WAS DEFECTIVE; THE DEFECTIVE PRODUCT WAS NOT RETURNED, BUT VIDEO EVIDENCE IS AVAILABLE. NO CLAIM IS REQUIRED; HOWEVER, A RESPONSE LETTER TO THE COMPLAINT AND A RECEIPT OF COMPLAINT ARE NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25057254 ↗MalfunctionApr 13, 2026Leak/Splash
IT WAS REPORTED THAT WE NOTICE A PROBLEM WITH THE BD INSYTE-W WITH LOT 5204426 CATHETER NEEDLES. THE TRANSITION BETWEEN CATHETER AND CONNECTION IS LEAKING. THIS HAS BEEN NOTICED BY SEVERAL NURSES. WE ARE GOING TO TRY TO KEEP TRACK OF DEFECTIVE CATHETERS. OUR PEDIATRICS DEPARTMENT HAS ESTABLISHED THAT THE BD INSYTE-W 24G X 19MM (REF 381312) IS A QUALITY ISSUE IN LOT 5204426. IS THIS SOMETHING YOU HAVE ALREADY HEARD FROM OTHERS?
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24861506 ↗MalfunctionMar 9, 2026Device Dislodged or Dislocated
ON (B)(6) 2026, AT 9:50 AM, DURING A VENIPUNCTURE PROCEDURE ON THE PATIENT, THE NEEDLE CORE DISLODGED MID-PROCEDURE. THE NEEDLE CORE STALLED DURING INSERTION, AND RESISTANCE WAS ENCOUNTERED UPON ENTERING THE VESSEL. TWO SUBSEQUENT ATTEMPTS USING NEEDLES OF THE SAME BRAND WERE UNSUCCESSFUL. A DIFFERENT BRAND OF INDWELLING NEEDLE WAS THEN USED, RESULTING IN A SUCCESSFUL PUNCTURE.
Patient problems: Discomfort
MAUDE report 24551638 ↗MalfunctionFeb 25, 2026Contamination /Decontamination Problem
ON (B)(6) 2026, 14:41. WHILE PREPARING TO PERFORM A VENIPUNCTURE ON PATIENT (BED (B)(6)), AN OPHTHALMOLOGY NURSE DISCOVERED A WHITE, DOT-LIKE FOREIGN SUBSTANCE ON THE SURFACE OF THE INDWELLING NEEDLE. THE DEVICE WAS IMMEDIATELY DISCONTINUED AND SEALED. A NEW INDWELLING NEEDLE WAS USED TO COMPLETE THE PROCEDURE. THE NURSE PROVIDED A THOROUGH EXPLANATION AND REASSURANCE TO THE PATIENT. NO HARM WAS CAUSED TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24443927 ↗MalfunctionJan 22, 2026Material Puncture/Hole
IT WAS REPORTED THAT "DURING USE THE NEEDLE PUNCTURED THE CATHETER".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24149645 ↗MalfunctionJan 8, 2026Fluid/Blood Leak
IT WAS REPORTED THAT BD INSYTE-W WINGED YEL 24GA X 0.75IN LEAKED AFTER ADMINISTERING AN IV INFUSION TO THE PATIENT, BLOOD LEAKAGE WAS OBSERVED AT THE CONNECTION POINT BETWEEN THE TUBING AND THE NEEDLE HUB.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24004101 ↗MalfunctionNov 13, 2025Fluid/Blood Leak; Fluid/Blood Leak
ON (B)(6) 2025, NURSING STAFF PLACED AN INTRAVENOUS CATHETER ON THE PEDIATRIC PATIENT TO FACILITATE INFUSION THERAPY. UPON INITIATING THE INFUSION AFTER CATHETER PLACEMENT, BLOOD WAS OBSERVED SEEPING FROM THE CONNECTION POINT BETWEEN THE NEEDLE TIP AND THE CATHETER BODY. THE INFUSION WAS IMMEDIATELY HALTED, THE CATHETER WAS REMOVED, AND A NEW CATHETER WAS INSERTED FOR USE. DUE TO THE TIMELY DETECTION, NO HARM WAS CAUSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23543437 ↗MalfunctionNov 3, 2025Leak/Splash; Material Integrity Problem; Leak/Splash; Material Integrity Problem
AFTER SUCCESSFUL VENOUS PUNCTURE, WHEN CONNECTING THE HEPARIN CAP, IT WAS DISCOVERED THAT THE BD CATHETER HAD SLIPPED, CAUSING FLUID LEAKAGE AT THE CONNECTION POINT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23453466 ↗MalfunctionOct 29, 2025Material Separation; Material Separation
ON (B)(6) , 2025, AT 2:20 PM, AN IV CATHETER WAS INSERTED FOR THE PEDIATRIC PATIENT. DURING THE PROCEDURE, FRESH BLOOD WAS OBSERVED LEAKING FROM THE PUNCTURE SITE. UPON CLOSER INSPECTION, THE NEEDLE HAD BECOME DETACHED. THE INFUSION WAS IMMEDIATELY HALTED, BLEEDING WAS CONTROLLED, THE PATIENT'S FAMILY WAS REASSURED, AND THE INFUSION THERAPY WAS RESUMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23415766 ↗MalfunctionOct 23, 2025Fluid/Blood Leak; Fluid/Blood Leak
ON (B)(6) 2025, AT 9:00 AM, THE PATIENT WAS ADMITTED FOR PNEUMONIA AND REQUIRED THIS INTRAVENOUS CATHETER. FOLLOWING PERIPHERAL CATHETER INSERTION, DURING THE APPLICATION OF THE ADHESIVE FILM, THE CATHETER CORE SPONTANEOUSLY DISLODGED, CAUSING BLOOD LEAKAGE. IMMEDIATE PRESSURE WAS APPLIED TO THE PUNCTURE SITE, AND A HEPARIN CAP WAS ATTACHED. THIS INCIDENT DID NOT ADVERSELY AFFECT THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23371803 ↗MalfunctionSep 11, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD INSYTE-W WINGED YEL 24GA X 0.75IN-LEAKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23029021 ↗MalfunctionSep 3, 2025Defective Component; Defective Component
IT WAS REPORTED THAT BD INSYTE-W WINGED YEL 24GA X 0.75IN - 381312 - NEEDLE HUB DEFECTIVE/DAMAGED. ON (B)(6) 2025, AT 09:30, WHILE PREPARING TO ADMINISTER INTRAVENOUS MEDICATION VIA A SINGLE-USE INTRAVENOUS CATHETER FOR PATIENT 48, IT WAS DISCOVERED THAT THE CONNECTION POINT LOOSENED EASILY DURING USE. THIS CAUSED THE NEEDLE TIP INTERFACE TO RETRACT INTO THE CATHETER, MAKING IT DIFFICULT TO PENETRATE THE SKIN. AFTER SUCCESSFULLY PIERCING THE SKIN, THE STEEL NEEDLE WAS IMMEDIATELY WITHDRAWN. HOWEVER, DURING THE PROCESS OF RECONNECTING THE HEPARIN CAP, BLEEDING BEGAN FROM THE WHITE ISOLATION CHAMBER. THE CATHETER WAS REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22953598 ↗MalfunctionAug 29, 2025Leak/Splash; Leak/Splash
THIS PR WILL BE CANCELLED AS IT IS A DUPLICATE OF (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22923727 ↗MalfunctionAug 25, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD INSYTE-W WINGED YEL 24GA X 0.75IN--LEAKAGE. VERBATIM: THERE IS BLEEDING AT THE CONNECTION BETWEEN THE END OF THE CATHETER AND THE INFUSION NEEDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22888483 ↗MalfunctionJun 5, 2025Defective Component; Defective Component
IT WAS REPORTED THAT BD INSYTE-W CONNECTOR DEFECTIVE THE PATIENT, A CHILD, WAS ADMITTED TO OUR DEPARTMENT DUE TO RAPID PUBERTY. ON (B)(6) 2025, THE NURSE USED A DISPOSABLE INTRAVENOUS CANNULA TO DRAW BLOOD FROM THE PATIENT ACCORDING TO THE DOCTOR'S INSTRUCTIONS. THE NURSE FOLLOWED THE ROUTINE PROCEDURE AND, AFTER SUCCESSFULLY PUNCTURING THE VEIN, CONNECTED THE PRN. HOWEVER, SHE FOUND THAT THE CANNULA CONNECTOR WAS DEFORMED AND THE PRN COULD NOT BE CONNECTED, CAUSING BLOOD TO LEAK OUT. AFTER THE INCIDENT, THE NURSE REMOVED THE NEEDLE TO STOP THE BLEEDING AND REPLACED THE CANNULA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22150192 ↗MalfunctionJun 2, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD INSYTE-W WINGED YEL 24GA X 0.75IN LEAKED AT ADAPTER TUBING JUNCTION ON (B)(6) 2025 A NEWLY OPENED SINGLE-USE IV INDWELLING NEEDLE OOZED FROM THE CONNECTOR AFTER A SUCCESSFUL PUNCTURE WITH A HEPARIN CAP ATTACHED, AND THE CONNECTOR CONTINUED TO OOZE AFTER THE HEPARIN CAP WAS REPLACED AND ATTACHED. THE IV INDWELLING NEEDLE WAS IMMEDIATELY REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22123929 ↗MalfunctionMar 4, 2025Defective Component; Defective Component
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21515367 ↗MalfunctionJan 23, 2025Leak/Splash; Leak/Splash
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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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