BD Insyte-W 381323Recalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 00382903813230), received between Dec 28, 2017 and Sep 11, 2026 — classified as 4 injuries, 42 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 46 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2026Fluid/Blood Leak; Nonstandard Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50736903 ↗
• MalfunctionMar 28, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT BD INSYTE-W WINGED BL 22GA X 1.0IN NEEDLE THROUGH CATHETER USE OF THE EMERGENCY TROLLEY NEED TO INSERT A LINE => BLUE CATHETER = THE CANULA PIERCES THE PLASTIC CATHETER WHEN I MOVE IT TO CHECK THAT THE DM IS WORKING PROPERLY. VALID FOR THE 2 CATHETERS ON THE EMERGENCY TROLLEY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21720638 ↗
• MalfunctionJan 30, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD INSYTE-W WINGED BL 22GA X 1.0IN LEAKED (B)(6) 2025 10: 38, IN THE CENTRAL OPERATING ROOM, THE 12TH OPERATING ROOM PERFORMED A LEFT CEREBELLAR PONTINE ANGLE LESION RESECTION ON THE PATIENT (B)(6). INTRAOPERATIVE MONITORING OF INVASIVE BLOOD PRESSURE WAS REQUIRED, AND A DISPOSABLE INTRAVENOUS INDWELLING NEEDLE WAS USED TO PUNCTURE THE RIGHT DORSALIS PEDIS ARTERY. THE PUNCTURE AND NEEDLE CORE PLACEMENT WERE SUCCESSFUL, BUT THEN IT WAS FOUND THAT THERE WAS CONTINUOUS BLEEDING FROM THE JUNCTION OF THE CATHETER AND NEEDLE. AFTER THE CATHETER WAS REMOVED, PRESSURE WAS APPLIED TO STOP THE BLEEDING, AND THE INDWELLING NEEDLE WAS REPLACED TO PUNCTURE THE LEFT DORSALIS PEDIS ARTERY. ANESTHESIA AND SURGERY THEN PROCEEDED SMOOTHLY. THIS PATIENT HAD DIFFICULTY WITH ARTERIAL PUNCTURE, AND RE-PUNCTURE INCREASED THE PATIENT'S PAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21277505 ↗
• MalfunctionNov 27, 2024Material Rupture; Material Rupture

  NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20800169 ↗
• InjuryAug 29, 2024Break; Break

  THE PATIENT UNDERWENT CONVENTIONAL ORTHOPEDIC SPINE SURGERY WITH UNSTABLE BLOOD PRESSURE, AND INVASIVE BLOOD PRESSURE MONITORING OF THE RADIAL ARTERY WAS PERFORMED ON (B)(6). ON THE SECOND POSTOPERATIVE DAY, THE BLOOD PRESSURE AND RESPIRATION WERE STABILIZED, AND THE MUSCLE STRENGTH OF THE LIMBS WAS RESTORED, AND INVASIVE ARTERIAL CANNULAE WERE REMOVED, AND THE CEPHALIC END OF THE CANNULAE WAS OBSERVED TO APPEAR TO BE FRACTURED INTO 2 SEGMENTS, WITH LOCALIZED REDNESS, SWELLING, AND DISCOMFORT IN THE AFFECTED AREA AFTER REMOVAL. BEDSIDE ULTRASONOGRAPHY DID NOT SHOW ANY OBVIOUS STUMP RETENTION IN THE BODY. THE PATIENT WAS TREATED WITH LOCALIZED ANTI-INFLAMMATORY AND ANTI-SWELLING MEDICATIONS, AND THE AFFECTED AREA WAS CLOSELY OBSERVED FOR ANY CHANGES, AND ULTRASONOGRAPHY WAS PERFORMED WHEN NECESSARY TO DETERMINE WHETHER THERE WAS ANY RESIDUAL STUMP RETENTION.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 20101882 ↗
• MalfunctionDec 6, 2023Break; Break

  WE RECEIVED THE FOLLOWING COMPLAINT FROM REF (B)(4) INSYTE W AILETTES PERIPHERAL INTRAVENOUS CATHETER 22G1" 0.9X25 MM : AFTER PRICKING THE PATIENT AND WITHDRAWING THE NEEDLE, THE NEEDLE SPLITS IN TWO. THIS IS LIFE-THREATENING FOR THE PATIENT. (SEE PHOTO ATTACHED). LOT NUMBER : 1321240 WHICH PROCEDURE SHOULD WE FOLLOW PLEASE ?

  Patient problems: Insufficient Information

  MAUDE report 18276277 ↗
• MalfunctionAug 16, 2023Defective Component; Defective Component

  IT WAS REPORTED THAT THE OUTER EDGE OF THE BD INSYTE¿ IV CATHETER NEEDLE WAS FOUND DEFORMED WHEN REMOVED FROM THE PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "WHEN PATIENTS USE DISPOSABLE INTRAVENOUS INDWELLING NEEDLES, CHECK THAT THE OUTER PACKAGING OF THE PRODUCT IS INTACT AND NOT DAMAGED BEFORE OPERATION, AND WHEN THEY ARE READY TO PUNCTURE, OPEN THE INDWELLING NEEDLES AND FIND THAT THE OUTER EDGE OF THE NEEDLE WITH WINGS IS DEFORMED AND WARPED, AND CANNOT BE OPERATED NORMALLY, SO THEY ARE GIVEN TO REPLACE THE INDWELLING NEEDLES AGAIN FOR OPERATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17560312 ↗
• MalfunctionAug 14, 2023Break; Defective Component; Break; Defective Component

  IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER BROKE WHEN THE NEEDLE WAS WITHDRAWN AND THE TIP WAS THICKENED. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: WHEN THE NEEDLE IS WITHDRAWN, THE CATHETER BREAKS. YOU NOTICE THAT THE TIP OF THE CATHETER IS THICKENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17546844 ↗
• InjuryAug 1, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER SEPERATED AND WAS LEFT IN THE PATIENT, HAD TO BE SURGICALLY REMOVED. THE FOLLOWING WAS RECIEVED BY THE INITIAL REPORTER: VERBATIM: THE NURSE REPORTED THAT THE PATIENT WAS INTUBATED UNDER GENERAL ANESTHESIA IN THE OPERATING ROOM ON (B)(6). AFTER THE OPERATION, THE INDWELLING NEEDLE WAS PULLED OUT AND IT WAS FOUND THAT THERE WAS NO FRONT END OF THE CATHETER, AND THE FRONT END OF THE TROCAR WAS LEFT IN THE PATIENT'S BODY. IT HAS BEEN REMOVED AFTER TIMELY SURGERY, AND HAS NOT CAUSED OTHER EFFECTS FOR THE TIME BEING.

  Patient problems: Foreign Body In Patient

  MAUDE report 17439237 ↗
• MalfunctionMay 15, 2023Material Perforation; Material Perforation

  IT WAS REPORTED WHILE USING BD INSYTE-W¿ IV CATHETER WITH WINGS 22 G X 1.00 IN THE CATHETER WAS DAMAGED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: I HAD A PROBLEM TODAY, (B)(6) 2023, DURING A PERIPHERAL CATHETER PLACEMENT IN THE PEDIATRIC EMERGENCY ROOM, ON AN 8 YEAR OLD PATIENT. SEVERAL CATHETERS WERE DEFECTIVE, SLIGHTLY PIERCED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16933966 ↗
• MalfunctionDec 23, 2022Material Puncture/Hole; Material Puncture/Hole

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16044487 ↗
• MalfunctionDec 22, 2022Defective Component; Defective Component

  IT WAS REPORTED THAT THE BD INSYTE¿ IV CATHETER NEEDLE BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: THE INNER CORE SLIPPED DURING VENIPUNCTURE, RESULTING IN VENIPUNCTURE FAILURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16034542 ↗
• MalfunctionDec 16, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED WHILE USING BD INSYTE-W¿ PERIPHERAL VENOUS CATHETER THE EXPERIENCED NEEDLE THROUGH CATHETER. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DUTCH TO ENGLISH: RECENTLY FOUND MULTIPLE NEEDLES ON L1 AND M2 WHERE IV NEEDLE IS DEFECTIVE. PLASTIC CATHETER IS ON HOOK. BASICALLY THIS A PROBLEM THAT DOES HAPPEN MORE OFTEN WHEN YOU'VE JUST MADE THE WRONG ANGLE AND ARE AGAINST THE VESSEL WALL, BUT COULD OF COURSE BE THAT IN THESE CASES PLASTIC WAS ALSO AFFECTED BEFOREHAND. HAVE ONLY SEEN IT WITH BLUE NEEDLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15993585 ↗
• MalfunctionOct 21, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD INSYTE¿ IV CATHETER BLOOD CONTROL FEATURE DID NOT WORK DURING USE WHEN THE INFUSION SET WAS NOT CONNECTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "WHEN MEDICAL STAFF PERFORMED INDWELLING NEEDLE INDWELLING EXERCISES, THEY FOUND THAT WHEN THE INFUSION SET WAS NOT CONNECTED, A LARGE AMOUNT OF BLOOD RETURNED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15653110 ↗
• MalfunctionJul 22, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE NEEDLE PIERCED THROUGH THE BD INSYTE¿ IV CATHETER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "ON (B)(6) 2022, WHEN THE ICU DEPARTMENT USED THE INDIGNANT NEEDLE, IT WAS FOUND THAT THE NEEDLE OF THE INDIGNANT NEEDLE HAD BEEN INSERTED OUT OF THE CATHETER TUBE, AND THERE WAS A SAFETY RISK OF USE. THE CLINICAL DEPARTMENT IMMEDIATELY REPLACED THE NEW CONSUMABLES AND REPORTED THEM TO THE EQUIPMENT DEPARTMENT FOR FOLLOW-UP TREATMENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15090037 ↗
• MalfunctionJul 11, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT 1 BD INSYTE-W¿ PERIPHERAL VENOUS CATHETER HAD NEEDLE THROUGH THE CATHETER ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM FRENCH TO ENGLISH : THE USER REPORTED THAT DURING A CATHETERIZATION OF A DOG WITH A CATHETER INSYTE BLUE THREAD 0.9X25MM, WHEN STARTING TO REMOVE THE MANDREL WITHOUT TAKING IT OUT COMPLETELY THERE WAS NO BLOOD RETURN SO IT WAS PUT BACK IN AND REALIZED THAT IT WAS BLOCKED AND A POTATO HAD FORMED AT THE VEIN. ON REMOVING THE CATHETER IT WAS NOTICE THAT THE MANDREL IS BLUNT AND HAD PIERCED THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14982770 ↗
• MalfunctionJun 27, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT THE BD INSYTE-W¿ IV CATHETER EXPERIENCED CATHETER DAMAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE CATHETER WAS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14830961 ↗
• MalfunctionJun 20, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE BD INSYTE¿ IV CATHETER NEEDLE PIERCED THROUGH THE CATHETER AFTER ENTERING THE VEIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: "ONCE IN THE VEIN THE BEVEL PIERCES THE CANNULA. THIS HAS HAPPENED SEVERAL TIMES. THE VET HAS BEEN USING OUR CATHETER FOR ABOUT TEN YEARS WITHOUT ANY PROBLEMS."

  Patient problems: Insufficient Information

  MAUDE report 14743607 ↗
• MalfunctionJun 16, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT 1 BD INSYTE-W¿ PERIPHERAL VENOUS CATHETER WAS FRAYED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER REPORTED THAT WHEN INSERTING A PIV, THE IV WAS DIFFICULT TO THREAD AND NOTED THE NEEDLE HAD SHREDDED THE TIP OF THE CATHETER HALF OFF. EVENT DATE: (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14721796 ↗
• MalfunctionApr 16, 2022Break; Break

  IT WAS REPORTED THAT BD INSYTE-W¿ IV CATHETER WITH WINGS 22GA 1.00IN WAS DAMAGED, BUT STILL OPERABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN ICU WAS PREPARING TO USE THE CONSUMABLE, THE METAL NEEDLE WAS FOUND TO HAVE A GAP WHEN THE PACKAGE WAS OPENED FOR INSPECTION, WHICH INDICATED THAT IT WAS SAFE TO USE"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14131504 ↗
• MalfunctionMar 31, 2022Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT BD INSYTE-W¿ IV CATHETER WITH WINGS 22GA 1.00IN HAD A NEEDLE THROUGH THE CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DURING AN INTRAVENOUS INFUSION, THE PLASTIC AROUND THE NEEDLE THAT SERVES AS A GUIDE WAS PIERCED BY THE NEEDLE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13966304 ↗
• MalfunctionDec 22, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A BD INSYTE-W¿ IV CATHETER WITH WINGS 22GA 1.00IN HAD A SEPARATION OF THE LUER CONNECTION AND LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " WHEN THE NEEDLE CORE IS NOT PULLED OUT DUE TO THE LOOSE CONNECTION BETWEEN THE CATHETER AND THE NEEDLE CORE, THE NEEDLE CORE AUTOMATICALLY EXITS UNDER ARTERIAL PRESSURE AND ARTERIAL BLOOD FLOWS OUT, AND THE SENSOR CONNECTOR IS IMMEDIATELY PRESSED AND CONNECTED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13063956 ↗
• MalfunctionDec 16, 2021Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED WHEN USING THE BD INSYTE-W WINGED BL 22GA X 1.0IN, THE DEVICE EXPERIENCED A DAMAGED OR OPEN UNIT PACKAGE WHERE THE STERILITY OF THE PRODUCT IS COMPROMISED. THIS EVENT OCCURRED 50 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: BURN SURGERY, PACKAGING DEGUMMING OF INSYTE NEEDLE HOLDER END.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13023471 ↗
• MalfunctionSep 10, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED WHEN USING THE BD INSYTE-W¿ IV CATHETER WITH WINGS 22GA 1.00IN THERE WAS FOREIGN MATTER ON DEVICE CANNULA/NEEDLE/CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE INDWELLING NEEDLE WAS REPLACED AFTER A HAIRY, FLOCK-LIKE FOREIGN BODY WAS FOUND AT THE TIP OF THE INDWELLING NEEDLE WHILE ADMINISTERING INFUSION TO THE PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12454373 ↗
• MalfunctionAug 3, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD INSYTE-W¿ IV CATHETER WITH WINGS 22GA 1.00IN HAD THE NEEDLE THROUGH THE CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT SEEMS THAT ON SEVERAL OCCASIONS, THE NEEDLE WOULD HAVE PIERCED THE CANNULA AFTER A BACK AND FORTH."

  Patient problems: No Information

  MAUDE report 10359666 ↗