BD Insyte-NRecalls & reported problems across all models

We found 2 models of BD Insyte-N by Becton, Dickinson And Company in the FDA's device registry (GUDID). Together they are named in 37 adverse event reports in the FDA's MAUDE database, received between Nov 27, 2017 and Jan 21, 2026 — classified as 1 death, 2 injuries, 34 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (7 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported BD Insyte-N problems

BD Insyte-N models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• BD Insyte-N 381311

  Catheter,intravascular,therapeutic,short-term less than 30 days
  1 death21 reports
• BD Insyte-N 381211

  Catheter,intravascular,therapeutic,short-term less than 30 days
  16 reports

Recent BD Insyte-N adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJan 21, 2026Nonstandard Device

  IT WAS REPORTED THAT BD INSYTE-N WINGED YEL 24GA X 0.56IN CATHETER DEFECTIVE / DAMAGED IT WAS REPORTED THAT "INDWELLING CATHETER IS DAMAGED DURING INSTALLATION" WHEN DID THE INCIDENT OCCUR? DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24132919 ↗
• MalfunctionSep 11, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT BD INSYTE-N WINGED YEL 24GA X 0.56IN-NEEDLE THROUGH CATHETER. DATE OF OCCURRENCE: (B)(6) 2025. INSERTION OF PERIPHERAL VENOUS CATHETERS IN TWO PREMATURE BABIES IN THE DEPARTMENT WHEN REMOVING THE CANULA AND THEN REINSERTING IT, THE CANULA PIERCED THE CATHETER ON THE WALL, MAKING IT IMPOSSIBLE TO INSERT THIS CATHETER. CLINICAL CONSEQUENCES OBSERVED: NECESSITY TO REPLACE WITH ANOTHER BATCH NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23030102 ↗
• MalfunctionSep 11, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT BD INSYTE-N WINGED YEL 24GA X 0.56IN-NEEDLE THROUGH CATHETER. DATE OF OCCURRENCE: (B)(6) 2025. INSERTION OF PERIPHERAL VENOUS CATHETERS IN TWO PREMATURE BABIES IN THE DEPARTMENT WHEN REMOVING THE CANULA AND THEN REINSERTING IT, THE CANULA PIERCED THE CATHETER ON THE WALL, MAKING IT IMPOSSIBLE TO INSERT THIS CATHETER. CLINICAL CONSEQUENCES OBSERVED: NECESSITY TO REPLACE WITH ANOTHER BATCH NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23029982 ↗
• 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 ↗
• MalfunctionJun 12, 2024Material Protrusion/Extrusion; Material Protrusion/Extrusion

  NEEDLE THROUGH IN CATHETER - BASED ON THE PICTURE AVAILABLE IN THE ATTACHMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19519230 ↗
• DeathJun 30, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING USE WITH BD INSYTE-N¿ AUTOGUARD¿ SHIELDED IV CATHETER DEATH OF AN INFANT OCCURRED AFTER ANTIBIOTIC INJECTION, THERE WAS NO REPORT OF ANY MALFUNCTION OF THE DEVICE. 1 OF 2 "POTENTIALLY USED" INSYTE¿ CATHETER REPORTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: DEATH OF AN INFANT A FEW MINUTES AFTER VENOUS INJECTION OF ANTIBIOTICS (AMOXICILINE AND GENTAMICIN). NO EXPLANATION TO DATE. STATEMENT CONCERNING 3 MODELS OF VENOUS CATHETER POTENTIALLY IN USE. THIS IS ASSOCIATED WITH ANOTHER STATEMENT CONCERNING THE SYRINGE PUMP, SYRINGE, TUBING AND NON-RETURN VALVE USED IN PARALLEL. CURRENT PATIENT STATUS : DEATH ACTIONS TAKEN IN THE CARE FACILITY TO MANAGE THE PATIENT: JUDICIAL INVESTIGATION, AUTOPSY

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17239826 ↗
• MalfunctionMar 18, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED WHILE USING BD INSYTE-N¿ IV CATHETERS THE NEEDLE PIERCED THE CATHETER. THIS OCCURRED 7 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: WHILE CHECKING THE CATHETER (AFTER PURGING BY INSERTING AND REMOVING THE NEEDLE IN THE PLASTIC GUIDE) THE NEEDLE GETS BLOCKED AND PIERCES THE GUIDE. RECURRENT PROBLEM ON 7 CATHETERS THAT DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16570081 ↗
• MalfunctionFeb 4, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED WHILE USING BD INSYTE-N¿ IV CATHETERS THE NEEDLE PIERCED THE CATHETER. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: DURING THE PREPARATION OF THE PKV, A DEFECTIVE PLASTIC CANNULA WAS DETECTED ON 3 PVKS. THIS IS INDICATED BY A SLIGHT CHANGE / THICKENING ON THE PLASTIC CANNULA. IF THE NEEDLE IS BRIEFLY WITHDRAWN OUTSIDE THE PATIENT AND THEN CAREFULLY ADVANCED AGAIN, THE PLASTIC CANNULA MAY BE PUNCTURED WITH THE NEEDLE IN THE AREA OF THE THICKENING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16301888 ↗
• MalfunctionJan 17, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT 1 BD INSYTE-N¿ IV CATHETER EACH FROM LOTS 2021235 AND 2140686 HAD ISSUES WITH THE NEEDLE PIERCING THROUGH CATHETER UPON INSERTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: "ATTEMPT TO INSERT A PERIPHERAL VENOUS LINE (VVP) ON A NEW 15 DAY OLD. WHEN CHECKING THE SLIDING OF THE TROCAR IN THE PLASTIC CASE OF THE VVP, THE TROCAR PIERCES THE PLASTIC CASE AT THE END. ALSO, SLIDING/INSERTING THE TROCAR INTO THE VVP IS NOT EASY AS THE PLASTIC EDGE OF THE NEEDLE TENDS TO HIT THE ENTRANCE OF THE VVP. CLINICAL CONSEQUENCES: LOSS OF TIME, STRESS FOR STAFF AND THE SURROUNDING FAMILY, CRYING OF THE BABY, RISK OF DAMAGING THE VEIN. PRECAUTIONARY MEASURES: CHANGE OF CATHETER".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16185966 ↗
• 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 ↗
• MalfunctionNov 9, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF THE BD INSYTE-N¿ IV CATHETER DETACHED FROM THE NEEDLE DURING THE PERFUSION OF A PREMATURE NEWBORN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: "ACCORDING TO OUR DEPARTMENT, THE TIP OF THE CATHETER BECAME DETACHED FROM THE NEEDLE DURING THE PERFUSION OF A PREMATURE NEWBORN, CAUSING A HAEMATOMA AND REQUIRING REPERFUSION. THE OFFENDING DEVICE WAS NOT RETAINED."

  Patient problems: Hematoma; Insufficient Information

  MAUDE report 15760763 ↗

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