BD Insyte-N 381311Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00382903813117), received between Nov 27, 2017 and Jan 21, 2026 — classified as 1 death, 2 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (5 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 21 most recent of 21 reports, 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionApr 19, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE NEEDLE PIERCED THROUGH THE BD INSYTE-N¿ IV CATHETER WHILE INTRODUCING IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTED: "SHE STITCHES IN WHEN SHE REPOSITIONS IT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14147433 ↗
• MalfunctionMar 17, 2022Defective Device; Defective Device

  IT WAS REPORTED WHILE USING BD INSYTE-N¿ PERIPHERAL VENOUS CATHETER THE TIP OF THE CATHETER WAS FOUND TO BE DEFECTIVE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AT THE TIME OF INSERTING THE NURSE TOOK THE DM OUT OF ITS PACKAGING. AT THE TIME OF PRICKING, IMPOSSIBLE TO PIERCE THE SKIN OF THE CHILD. LOOKING MORE CLOSELY, SHE REALIZES THAT THE CATHETER IS DEFECTIVE AT ITS DISTAL END (ENTRY POINT).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13802356 ↗
• MalfunctionNov 6, 2020Leak/Splash; Device Contamination with Chemical or Other Material; Leak/Splash; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A INSYTE-N WINGED YEL 24GA X 0.56IN HAD THE NEEDLE THROUGH THE CATHETER AND A SPLIT CATHETER DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "WE HAVE BEEN INFORMED OF A MALFUNCTION WITH THE (B)(4) REFERENCE DEVICE. THE SERVICE INFORMS US THAT FOR SEVERAL MONTHS NOW, 50% OF THIS MATERIAL IS UNUSABLE WHEN OPENING. THE BEVEL OF THE NEEDLE IS ORIENTED ON THE WRONG SIDE AND WHEN THE CAREGIVERS READJUST THE POSITIONING OF THE BEVEL, THE CATHETER SPLITS OR IS PIERCED. ALL LOTS ARE AFFECTED BY THIS PROBLEM. THE AFFECTED DEVICE IS AT YOUR DISPOSAL. THERE WERE NO PATIENT CONSEQUENCES. AS STATED IN THE REPORT, THESE INCIDENTS ARE FREQUENT (50% OF THE EQUIPMENT IS UNUSABLE). NO INCRIMINATED DEVICE HAS BEEN KEPT, THIS INCIDENT OCCURRING ONCE OUT OF TWO TIMES. HOWEVER, UNUSED DEVICES OF THE SAME REFERENCE WERE SET ASIDE."

  Patient problems: No Patient Involvement

  MAUDE report 10805669 ↗
• MalfunctionOct 13, 2020Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT THE BD INSYTE-N¿ IV CATHETER TIP WAS DAMAGED AND LEAKED. THIS OCCURRED 5 DIFFERENT TIMES DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "AT THE TIME OF INSERTION OF THE CATHETER INTO THE VEIN THERE WAS A LEAK FROM THE SIDE (THE SPACE BETWEEN THE NEEDLE AND THE CATHETER) AND THE BACK CHAMBER DID NOT FILL WITH BLOOD. ALSO, THE TIP OF THE CATHETER WAS DAMAGED (I.E. THE TRANSPARENT SILICONE WAS SHORTER THAN THE NEEDLE ITSELF) THE CUSTOMER USING THE INSYTE -W (381312), BY MISTAKE THEY RECEIVED THE INSYTE-N (381311) - SO IN THEIR CARTS THEY HAD BOTH OF THEM. THEY CLAIM THE LEAK HAPPENED FROM BOTH PRODUCTS."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10668543 ↗
• MalfunctionDec 16, 2019Leak/Splash; Device Contamination with Chemical or Other Material; Leak/Splash; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE SHIELD WAS DIFFICULT TO REMOVE FROM THE BD INSYTE-N¿ IV CATHETER, AND DOING SO CAUSED THE CATHETER TO DISCONNECT FROM THE HUB. THIS MADE IT "IMPOSSIBLE" TO PUT THE NEEDLE BACK INTO THE SHEATH, WHICH THE NEEDLE PIERCED THROUGH AND CAUSED THE CATHETER TIP TO "FOLD". ADDITIONALLY, IT WAS REPORTED THAT THE NEEDLE WAS "UNSTABLE" AND "ROTATED ON ITSELF" IN THE CATHETER, CAUSING A PERFORATION ON THE SHEATH. LOT#S 8326824, 8136218, AND 9081618 WERE REPORTED TO HAVE HAD OCCURRENCES OF ALL EVENTS, BUT IT IS UNKNOWN HOW MANY HAPPENED WITHIN EACH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: ". 1. THE CAP IS VERY DIFFICULT TO REMOVE. 2. WHEN THE CAP IS REMOVED, IT OFTEN DISCONNECTS THE CATHETER FROM THE NEEDLE AND IT IS IMPOSSIBLE TO PUT THE NEEDLE BACK INTO THE SHEATH BECAUSE THE SHEATH IS PIERCED BY THE NEEDLE. 3. THE NEEDLE ROTATES ON ITSELF IN THE CATHETER, WHICH AGAIN INDUCES A PERFORATION OF THE PLASTIC SHEATH AND NO STABILITY DURING THE PAUSE. 4. DURING THE TEST IF THE NEEDLE MOVES IN THE PLASTIC SHEATH, THE SHEATH IS ALSO PUNCTURED AND THE TIP OF THE CATHETER FOLDS. 5. THE NEEDLE IS NOT STABLE IN THE CATHETE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9473957 ↗
• MalfunctionAug 1, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT CATHETER MALFUNCTION OCCURRED AT AN UNSPECIFIED TIME WITH A BD INSYTE-N¿IV CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "THE USER HAS BEEN WORKING WITH THE PRODUCT FOR A LONG TIME AND LOOSENS THE NEEDLE ON THE VENOUS INDWELLING CANNULA AS RECOMMENDED, JUST BEFORE IT IS USED ON THE PATIENT. THEN, WHEN REPOSITIONING THE CANNULA, THE PIERCING OF THE CATHETER MATERIAL OCCURS."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8852601 ↗
• MalfunctionApr 30, 2019Restricted Flow rate; Obstruction of Flow

  IT WAS REPORTED THAT THE BD INSYTE-N¿ IV CATHETER TIP WAS DAMAGED AND DID NOT ALLOW LIQUID TO FLOW THROUGH IT DURING USE. TESTS PERFORMED ON THE DEVICE CONFIRMED THE CATHETER WAS CLOGGED, AS THE PURGE WITH "NACL" DID NOT WORK, AND LIQUID CAME OUT AT THE LEVEL OF THE SCREW THREAD RATHER THAN AT THE LEVEL OF THE BEVEL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: BEVELLED END DOES NOT WORK, THE LIQUID CANNOT FLOW. CONSEQUENCES: HEALTHCARE WORKERS CANNOT MAKE A REFLUX, CATHETER NOT USABLE. TESTS DONE ON DIFFERENT CATHETERS: WE NOTICE THE CATHETER IS CLOGGED. PURGE WITH NACL DOES NOT WORK. FOR THE SAME BATCH SOME CATHETERS ARE CLOGGED AND OTHERS ARE WORKING PROPERLY. BEFORE PLACING THE CATHETER THE NURSE PURGES THE CATHETER WITH NACL. IT CAN BE SEEN THAT THE LIQUID COMES OUT AT THE LEVEL OF THE SCREW THREAD. NOT AT THE LEVEL OF THE BEVEL. VISUALLY THE BEVEL IS NORMAL.

  Patient problems: No Information

  MAUDE report 8565483 ↗
• MalfunctionApr 25, 2019Break

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF 24G X 0.56IN (0.7 X 14 MM) INSYTE EXPERIENCED PRODUCT DAMAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AT THE TIME OF THE INSTALLATION OF THE DEVICE, YELLOW CATHETER, DURING THE PURGE OF THE CATHETER, PURGE IS IMPOSSIBLE. IT IS POSSIBLE TO PURGE THE NEEDLE AND CATHETER SEPARATELY BUT NOT TOGETHER. CUSTOMER ADDED THE FOLLOWING INFO AFTER QUESTION: IT IS TRUE THAT IN THE PRACTICES OF USE OF A SHORT CATHETER, IT IS NOT FREQUENT TO PURGE IT BEFORE USE BUT IN NEONATOLOGY IT IS PURGED BEFORE PUNCTURING THE VEIN, THIS IS EXPLAINED BY THE FACT THAT OUR PATIENTS HAVE A LOW VENOUS RETURN AND THIS PRACTICE FACILITATES CATHETER PLACEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8549910 ↗
• MalfunctionMar 7, 2019Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE 24G X 0.56IN (0.7 X 14 MM) INSYTE EXPERIENCED FOREIGN MATTER CONTAMINATION. THE CUSTOMER REPORTED, "THERE IS RESISTANCE WHEN INFUSING WITH THESE CATHETERS, IT IS IMPOSSIBLE TO INSTAL IT INTO THE VEIN. WHEN REMOVING THE CATHETER, A PIECE OF PLASTIC I VISIBLE COMING OFF THE SYSTEM (AT THE END OF THE CATHETER). THE CONSEQUENCES FOR THE PATIENT ARE DETERIORATION OF THE VEIN AND MULTIPLE INFUSIONS REQUIRED.¿

  Patient problems: Tissue Damage

  MAUDE report 8401533 ↗
• MalfunctionMar 5, 2019Fail-Safe Problem

  IT WAS REPORTED THAT THE 24G X 0.56 IN (0.7 X 14 MM) INSYTE EXPERIENCED A GENERAL SAFETY ISSUE WITH THE CUSTOMER STATING "THE CATHETER PART THAT STAYS IN THE ARM OF THE PATIENT (NEWBORN) IS PIERCED AND ALMOST FULLY CUT."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8392314 ↗
• InjuryOct 10, 2018Material Separation

  IT WAS REPORTED THAT THE CATHETER SPLIT WHILE TRYING TO INSERT A BD INSYTE-N PERIPHERAL VENOUS CATHETER, REQUIRING ADDITIONAL IV ATTEMPTS. IT WAS REPORTED THAT THE PATIENT WAS SEPTIC AND THIS DELAYED THEIR ¿URGENT IV ANTIBIOTICS¿. NO ADDITIONAL MEDICAL INTERVENTIONS WERE REPORTED.

  Patient problems: Sepsis

  MAUDE report 7953632 ↗
• InjuryNov 27, 2017Break

  IT WAS REPORTED THAT THE 24 G X 0.56 IN. BD INSYTE-N¿ PERIPHERAL VENOUS CATHETER BROKE OFF INSIDE AN INFANT. THE PIECE HAD TO BE SURGICALLY REMOVED AND DISCARDED. THIS MDR REPORTABLE IS CONSIDERED A SERIOUS INJURY AND MEDICAL INTERVENTION TOOK PLACE.

  Patient problems: No Code Available

  MAUDE report 7060554 ↗