BD Insyte-N 381211Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00382903812110), received between Oct 25, 2018 and Aug 13, 2025 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Defective Component” (4 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT BD INSYTE-N YEL 24GA X 0.56IN CATHETER DEFECTIVE/ DAMAGED IT WAS REPORTED THAT THE BABY IS CANNULATED, THE CATHETER PACKAGING IS OPENED, THE CATHETER IS LOOSENED FROM THE CORE AND WHEN THIS PROCEDURE IS PERFORMED THE CORE GOES TO ONE SIDE (IT TWISTS WHEN THE CATHETER IS REMOVED) THE CATHETER IS LOOSENED IN A VERY DELICATE WAY. LOT NUMBER: 4058321. THE CATHETER IS KEPT; IT IS IN THE OFFICE. ADDITIONAL INFORMATION RECEIVED ON 07/30/2025 IS THERE ANY PATIENT IMPACT, IF YES, PLEASE EXPLAIN IN DETAIL? A: THERE WAS NO IMPACT ON THE PATIENT. COULD YOU PLEASE SHARE THE PHOTO SAMPLES RELATED TO THIS EVENT? A: EVIDENCE IS SENT CAN YOU PLEASE CONFIRM THE AFFECTED QUANTITY? A: 1 UNIT FOR SAMPLE COLLECTION: PLEASE INFORM: THE SAMPLE HAS ALREADY BEEN SHIPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22794089 ↗
• MalfunctionFeb 10, 2025Crack; Crack

  ADDITIONAL INFO RECEIVED _ FEB 03.2025. COULD YOU PLEASE RECONFIRM THE MATERIAL AND LOT NUMBER? THE MATERIAL PROVIDED IN THE REPORT AND THE IMAGE ARE DIFFERENT. PLEASE CONFIRM THE NUMBER OF THE MATERIAL CONCERNED. LOT: 4058321. COULD YOU PLEASE CONFIRM IF THE QUANTITY AFFECTED IS 2? YES. WAS THERE ANY IMPACT ON THE HEALTH OF THE PATIENTS? DETAIL. YES BUT WITHOUT PATIENT'S DATA. FOR SPECIMEN COLLECTION: REPORT THE FOLLOWING: HOW MANY UNITS ARE AVAILABLE FOR COLLECTION? TWO. IS THE SAMPLE CONTAMINATED? IF YES, INDICATE THE SUBSTANCE. NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21344957 ↗
• MalfunctionJan 28, 2025Defective Component; Defective Component

  TWO MEDICAL OFFICERS HAVE REPORTED DIFFICULTIES WITH USE - CAP DIFFICULT TO REMOVE AND CAN NO LONGER BE DONE WITH ONE HAND, ONCE CAP IS OFF, THE CANNULA TIP / THREADING TIP IS MOVING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21253750 ↗
• MalfunctionJan 2, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT BD INSYTE-N YEL 24GA X 0.56IN CATHETER DEFECTIVE / DAMAGED. DATE OF OCCURRENCE: (B)(6) 2024. INCIDENT DESCRIPTION: DURING A VVP INSERTION ON A 4-MONTH-OLD BABY, WE OPENED THE CATHETER PACKAGING AND REMOVED THE CATHETER FROM ITS CASE. IT WAS DEFECTIVE (BROKEN PIECE OF PLASTIC), PREVENTING VVP INSERTION. THIS IS NOT THE FIRST TIME THIS HAS HAPPENED TO US. HAPPENED. SOMETIMES IT HAPPENS WHEN WE'VE PRICKED THE BABY. THE PLASTIC TIP DEFLECTS, WEAKENING THE VEIN UNTIL IT RUPTURES. RUPTURE. THIS FORCES US TO PRICK THE CHILD SEVERAL TIMES. PATIENT INFORMATION: PATIENT'S CURRENT CONDITION: CATHETER CHANGE, WE TOOK ANOTHER CATHETER HAVING NOTICED THE DAMAGE BEFORE PRICKING, BUT THIS IS NOT THE CASE. BUT THIS IS NOT ALWAYS THE CASE. ACTIONS TAKEN IN THE CARE FACILITY TO MANAGE THE PATIENT: CATHETER CHANGED, WE TOOK ANOTHER ANOTHER CATHETER HAVING NOTICED THE DAMAGE BEFORE PRICKING, BUT THIS IS NOT ALWAYS THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21060045 ↗
• MalfunctionJan 2, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT BD INSYTE-N YEL 24GA X 0.56IN CATHETER DEFECTIVE / DAMAGED DATE OF OCCURRENCE:(B)(6) 2024. INCIDENT DESCRIPTION: DURING A VVP INSERTION ON A 4-MONTH-OLD BABY, WE OPENED THE CATHETER PACKAGING AND REMOVED THE CATHETER FROM ITS CASE. IT WAS DEFECTIVE (BROKEN PIECE OF PLASTIC), PREVENTING VVP INSERTION. THIS IS NOT THE FIRST TIME THIS HAS HAPPENED TO US. HAPPENED. SOMETIMES IT HAPPENS WHEN WE'VE PRICKED THE BABY. THE PLASTIC TIP DEFLECTS, WEAKENING THE VEIN UNTIL IT RUPTURES. RUPTURE. THIS FORCES US TO PRICK THE CHILD SEVERAL TIMES. PATIENT INFORMATION: PATIENT'S CURRENT CONDITION: CATHETER CHANGE, WE TOOK ANOTHER CATHETER HAVING NOTICED THE DAMAGE BEFORE PRICKING, BUT THIS IS NOT THE CASE. BUT THIS IS NOT ALWAYS THE CASE. ACTIONS TAKEN IN THE CARE FACILITY TO MANAGE THE PATIENT: CATHETER CHANGED, WE TOOK ANOTHER ANOTHER CATHETER HAVING NOTICED THE DAMAGE BEFORE PRICKING, BUT THIS IS NOT ALWAYS THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21058727 ↗
• MalfunctionDec 9, 2022Material Perforation; Material Perforation

  IT WAS REPORTED THAT 3 BD INSYTE-N¿ AUTOGUARD¿ SHIELDED IV CATHETERS EXPERIENCED THE NEEDLE PIERCING THROUGH THE CATHETER DURING CATHETER INTRODUCTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN THE NEEDLE IS INSERTED IT PIERCES THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15947871 ↗
• MalfunctionJun 24, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED BY THE CUSTOMER THAT DURING USE THE, BD INSYTE-N¿ AUTOGUARD¿ SHIELDED IV CATHETER PIERCED THE CATHETER DURING REINSERTION AND WAS UNUSABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT TURNS OUT THAT THE NEEDLE PIERCES THE CATHETER DURING REINSERTION, MAKING IT UNUSABLE. THIS HAS HAPPENED MANY TIMES IN THE LAST MONTH."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14807905 ↗
• MalfunctionFeb 9, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT BD INSYTE-N¿ IV CATHETER HAD A NEEDLE THROUGH THE CATHETER WHILE INTRODUCING THE CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE STYLET OF SEVERAL BD INSYTE VENOUS CATHETERS 0.7X14MM WERE DRILLED DURING LAYING BY THE GUIDE RESULTING IN INSTALLATION FAILURE."

  Patient problems: Insufficient Information

  MAUDE report 13499170 ↗
• MalfunctionSep 9, 2021Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED WHEN USING THE INSYTE-N YEL 24GA X 0.56IN, THE DEVICE EXPERIENCED A NEEDLE THROUGH CATHETER WHILE TRYING TO INTRODUCE THE CATHETER CAUSING A HOLE IN THE CATHETER ITSELF. THIS EVENT OCCURRED TEN TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: REPORTS OF RUPTURED CANNULA OCCURRING IN PACKAGING. ADDITIONAL REPORTS OF INSERTERS LOOSENING THE NEEDLE OFF THE PLASTIC HUB PRIOR TO INSERTION & THE NEEDLE IS RUPTURING THROUGH THE SIDE OF THE CANNULA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12450614 ↗
• MalfunctionAug 12, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT 2 BD INSYTE-N¿ IV CATHETERS 24GA 0.56IN EXPERIENCED A NEEDLE THAT PIERCED THROUGH THE NEEDLE COVER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NURSES AND REGISTRAR NOTED ON PREPARING FOR IV CANNULAR INSERTION, BD INSYTE-N 24 GA 14MM, THAT THE NEEDLES WERE GOING THROUGH THE SIDE OF THE PLASTIC SLEEVE, ALSO ONE WE OPENED HAD A RIGHT ANGLE BEND AT ITS TIP. REGISTRAR WENT TO INSERT IV CANNULAR INTO 3MONTH OLD BABY, BUT THE GUIDING NEEDLE HAD GONE OUT THE SIDE OF PLASTIC SLEEVE (PART THAT IS LEFT IN VEIN) THIS PRICKLED SKIN BUT COULD NOT BE ADVANCED SO FAILED AND HAD TO RE-CANNULATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12316669 ↗
• MalfunctionAug 12, 2021Break; Break

  IT WAS REPORTED THAT 2 BD INSYTE-N¿ IV CATHETERS' TIPS WERE DAMAGED AND BREAKING OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE CLINICIAN NOTICED THAT THE PLASTIC CANNULA TIP APPEARED TO BE BREAKING OFF.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12314350 ↗
• MalfunctionJun 3, 2021Break; Break

  IT WAS REPORTED THAT INSYTE-N YEL 24GA X 0.56IN CATHETER TIP WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEONATAL CATHETER # 24 WHEN REMOVING IT FROM THE PACKAGING IS OBSERVED THE RUPTURED CATHETER TIP, QUALITY QUESTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11935842 ↗
• MalfunctionFeb 5, 2020Leak/Splash; Device Contamination with Chemical or Other Material; Leak/Splash; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE BD INSYTE¿ IV CATHETER SPLIT WHEN ASSEMBLED AND INSERTED INTO THE PATIENT DURING USE, LEAVING THE NEEDLE EXPOSED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "ONCE THE CATHETER WAS ASSEMBLED AND INSTALLED ON THE PATIENT, A SLIT APPEARED ALONG THE ENTIRE LENGTH OF THE PLASTIC BODY OF THE CATHETER, LEAVING THE NEEDLE BARE."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9671394 ↗
• MalfunctionJul 23, 2019Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT WHILE INSERTING CATHETER, TUBING BECAME KINKED WITH A BD INSYTE¿-N YEL 24GA X 0.56IN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: PERIPHERAL CATHETER THAT WHEN TRYING TO CHANNEL THE PATIENT PRESENTS KINKING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8817462 ↗
• MalfunctionJun 19, 2019Leak/Splash; Device Contamination with Chemical or Other Material; Leak/Splash; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DEFECTS OCCURRED DURING USE WITH A 24G X 0.56IN (0.7 X 14 MM) INSYTE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "CUSTOMER DESCRIPTION: DIFFICULTY TO PIERCE THE SKIN. PLASTIC TIP NOT ALWAYS INTACT WHEN NEEDLE IS PROGRESSED THROUGH PLASTIC. SEVERAL CLINICIANS HAVE HAD ISSUES WITH THIS CANNULA. CANNULA ROTATES, NO LOCK . ONE CANNULA SPLIT."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8713436 ↗
• MalfunctionOct 25, 2018Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND IN THE BD INSYTE¿ IV CATHETER. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8005744 ↗