BD Insyte 381234Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00382903812349), received between Nov 27, 2017 and Jun 3, 2026 — classified as 4 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (9 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 3, 2026Nonstandard Device

  "IT WAS REPORTED THAT INTRAVENOUS CATHETER 20G VIALON 381234 LOT 4177835 FV 30/06/2029, WHICH ACCORDING TO THE REPORT ¿WHEN THE PATIENT IS PUNCTURED, THE CHAMBER IS NOT FULL AND WHEN IT IS RETRACTED, THE CATHETER IS DAMAGED AND MANY TIMES THE CORE DOES NOT PIERCE THE SKIN, BESIDES THEY ARE ALMOST BLUNT¿. MEDICAL DEVICE AVAILABLE FOR EVALUATION? YES, HAS THE DEVICE BEEN USED MORE THAN ONCE? YES".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25378248 ↗
• MalfunctionMar 31, 2026Separation Problem

  IT WAS REPORTED THAT THE CATHETER CAME OFF THE NEEDLE DURING IV INSERTION. IT WAS REPORTED THAT MULTIPLE IV ATTEMPTS AS THE JELCOS PLASTIC CANNULA "FALLS OFF " THE NEEDLES AND TRYING TO ATTEMPT TO ADVANCE THE CANNULA, THE CANULA BENDS AND DOES NOT WORK PROPERLY. ADDITIONAL INFORMATION 3/24/2026: WAS THE DEVICE BEING USED IN/ON PATIENT WHEN THE ISSUE OCCURRED? IN PATIENT. WAS PATIENT OR USER HARMED? IF YES, PLEASE EXPLAIN NO. WAS ADDITIONAL MEDICAL INTERVENTION/MEDICATION REQUIRED? NO. COULD YOU PLEASE PROVIDE A DATE OF EVENT? 17 FEBRUARY 2026. PLEASE CONFIRM THE NUMBER OF PRODUCTS AFFECTED. END USER COULD NOT CONFIRM AS THE COMPLAINT WAS FOR ALL WARDS AND THEATRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24741650 ↗
• MalfunctionFeb 2, 2026Leak/Splash

  IT WAS REPORTED THAT, DURING INJECTIONS OF CONTRAST MEDIUM FOR CT SCANS, LEAKAGE AT THE LUER CONNECTION BETWEEN THE CATHETER AND THE EXTENSION PIECE (PVC 75CM ROBINET 3V REF PS3307M CAR) ARE OBSERVED. THE INCIDENT OCCURRED SEVERAL TIMES, FOR THE SAME BATCH OF CATHETERS. NO LEAKAGE WAS OBSERVED WITH ANOTHER BATCH OF CATHETERS AND THE SAME EXTENSIONS. CLINICAL CONSEQUENCES - UNABLE TO INJECT CONTRAST MEDIUM. NEED TO INSERT ANOTHER PERIPHERAL VENOUS LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24235737 ↗
• MalfunctionFeb 2, 2026Leak/Splash

  IT WAS REPORTED THAT, DURING INJECTIONS OF CONTRAST MEDIUM FOR CT SCANS, LEAKAGE AT THE LUER CONNECTION BETWEEN THE CATHETER AND THE EXTENSION PIECE (PVC 75CM ROBINET 3V REF PS3307M CAR) ARE OBSERVED. THE INCIDENT OCCURRED SEVERAL TIMES, FOR THE SAME BATCH OF CATHETERS. NO LEAKAGE WAS OBSERVED WITH ANOTHER BATCH OF CATHETERS AND THE SAME EXTENSIONS. CLINICAL CONSEQUENCES - UNABLE TO INJECT CONTRAST MEDIUM. NEED TO INSERT ANOTHER PERIPHERAL VENOUS LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24235716 ↗
• MalfunctionSep 17, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD INSYTE PNK 20GA X 1.16IN LEAKAGE AT CATHETER JUNCTION. WHEN CONNECTING THE INFUSION TO THE CATHETER HUB, LEAKAGE OCCURS AT THE CONNECTION. AS A RESULT, THE CATHETER MUST BE REINSERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20239071 ↗
• MalfunctionJun 6, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE BD INSYTE¿ IV CATHETER EXPERIENCED FOREIGN MATTER IN FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TWO FOREIGN PARTICLES WERE DETECTED BY THE DOCTOR WHEN PLACING THE CANNULA, THEY WERE LOCATED ON THE CANNULA BEVEL / ON THE APERTURE OF THE CANNULA, AT THE BEGINNING OF THE CANNULA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17075740 ↗
• MalfunctionMay 11, 2023Defective Component; Defective Component

  IT WAS REPORTED WHILE USING BD INSYTE¿ IV CATHETER 20 G X 1.16 IN. THE CATHETER WAS DAMAGED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS FEEDBACK FROM OPERATING ROOM OF ANESTHESIA DEPARTMENT. NURSES COMPLAINED THAT THE NEEDLE IS BLUNT WHEN INSERTING IV CATHETER. WHEN FAILING IN INSERTING CATHETER, NURSE WITHDREW CATHETER AND SAW THAT THE CATHETER WAS BROKEN AT THE TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16915826 ↗
• InjuryMar 15, 2023Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT THE BD INSYTE¿ IV CATHETERS CATHETER BROKE AND A PIECE WAS LEFT IN THE PATIENT VEIN. THE REMANENT PIECE FROM THE VEIN WAS SUCCESSFULLY REMOVED AND AN ULTRASOUND WAS COMPLETED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONCERNS A COMPLAINT ABOUT A BROKEN INSYTE CATHETER. DESCRIPTION: WHEN THE PATIENT WOKE UP RESTLESSLY, TRACTION OCCURRED ON THE IV LINE. THIS CAUSED THE CATHETER TO BREAK, LEAVING A PIECE IN THE PATIENT'S VEIN. THEY WERE ABLE TO REMOVE THE REMAINING PIECE FROM THE VEIN AND AN ULTRASOUND WAS DONE OF THE INSERTION POINT, ON WHICH NO ABNORMALITIES COULD BE SEEN.

  Patient problems: Foreign Body In Patient

  MAUDE report 16549763 ↗
• InjuryDec 21, 2022Break; Break

  IT WAS REPORTED THAT THE BD INSYTE¿ IV CATHETER EXPERIENCED BREAKAGE REQUIRING SURGICAL INTERVENTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: UPON ADVANCING THE IVC, IT "SCRUNCHED" UP AND FORMED A KINK. AT THIS POINT, THE IVC HAD TO BE REMOVED, SO NURSE APPLIED PRESSURE ON THE IV SITE AND PULLED OUT THE IVC ONLY TO REALIZE THAT THE FRONT BIT OF THE PLASTIC WAS STUCK INSIDE THE DOG'S FOREARM. SURGEON SUBSEQUENTLY OPERATES ON THE DOG TO REMOVE THE STUCK PIECE

  Patient problems: Foreign Body In Patient

  MAUDE report 16030782 ↗
• MalfunctionJul 21, 2022Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT THE BD INSYTE¿ IV CATHETER BROKE FROM ITS HUB AFTER REMOVING THE MANDREL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE DISTAL END OF THE CATHETER BECOMES DETACHED WHEN THE MANDREL IS REMOVED, LEADING TO CASES OF VENITIS.

  Patient problems: Vasculitis

  MAUDE report 15080700 ↗
• MalfunctionJul 6, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE BD INSYTE¿ IV CATHETER SPLIT APART DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: "THE FLEXIBLE PART SOMETIMES CUTS IN TWO".

  Patient problems: Pain

  MAUDE report 14936442 ↗
• MalfunctionNov 24, 2021Break; Break

  IT WAS REPORTED THAT 3 BD INSYTE¿ IV CATHETERS BROKE FROM THEIR HUBS AFTER PLACING THEM IN THE PATIENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PLASTIC CANNULAS BROKE WHILST CANNULATING PATIENTS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12870581 ↗
• MalfunctionNov 24, 2021Material Perforation; Material Perforation

  IT WAS REPORTED THAT THE BD INSYTE¿ IV CATHETER EXPERIENCED THE NEEDLE THROUGH THE CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RECENT REPORT FROM EXPERIENCED NURSES OF DIFFICULTIES IN FITTING INSYTE CATHETERS AFTER VENOUS RETURN WITH PATIENT COMPLAINTS OF PAIN, PROBABLE EXTRAVASATION, CATHETER PUNCTURED BY NEEDLE MANDREL. NURSES FEEL THAT THE NEEDLE'S MANDREL IS MUCH SOFTER THAN USUAL, IT IS MORE EASILY BENT. NO LEAKS, THE CONCERN ARISES FROM TIME TO TIME DURING FITTING, SOMETIMES EVEN WHEN THERE WAS GOOD VENOUS CAPITAL. NO EXPOSURE TO THE BLOOD, NO CONTACT WITH BLOOD, IT IS DURING THE MANIPULATION, FAILURE OF THE ASSEMBLY, PAIN FOR THE PATIENT.

  Patient problems: Bruise/Contusion; Extravasation; No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 12869034 ↗
• MalfunctionSep 14, 2021Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT INSYTE PNK 20GA X 1.16IN NEEDLE WENT THROUGH THE CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT CAME IN FOR A BLOOD TEST. THE PATIENT HAD THICKER/HARDER SKIN. WHEN PENETRATING THE SKIN, THE CATHETER DEFORMED, TURNED OVER AND ONLY THE NEEDLE WAS INSERTED. THIS CAUSED THE PATIENT PAIN. THE CATHETER HAD BEEN CHECKED PRIOR TO USE, AND NO PROBLEMS WERE NOTED. LOCAL PAIN ON PUNCTURE. FROM INVESTIGATION: "ONE SAMPLE WITH OPEN PACKAGING WAS RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. THE SAMPLE WAS SUBJECTED TO VISUAL INSPECTION TO CHECK FOR CATHETER DAMAGE. FROM THE RETURNED SAMPLE, THE NEEDLE PIERCED THROUGH THE CATHETER TIP WAS OBSERVED. NO CANNULA BEVEL DAMAGE WAS OBSERVED."

  Patient problems: Pain

  MAUDE report 12467655 ↗
• InjuryNov 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT INSYTE PNK 20GA X 1.16IN WAS USED AND CAUSED REDNESS, SWELLING, AND PAIN AND ULTRASONOGRAPHY WAS PERFORMED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN THE INDWELLING NEEDLE WAS USED TO THE 3RD DAY, THE LOCAL REDNESS, SWELLING AND PAIN WERE OBVIOUS, WITH PURULENT SECRETIONS. B - ULTRASONOGRAPHY WAS PERFORMED AFTER THE DIAGNOSIS OF "SUPERFICIAL VENOUS THROMBOSIS". ANTICOAGULANT TREATMENT FOR 3 MONTHS. ANALYSIS: IT IS RELATED TO THE MATERIAL OF INDWELLING NEEDLE.

  Patient problems: Skin Inflammation

  MAUDE report 10797572 ↗
• MalfunctionAug 20, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD INSYTE¿ IV CATHETERS EXPERIENCED NEEDLE THROUGH THE CATHETER DURING INTRODUCTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN PUNCTURING A PATIENT WITH A PINK NO. 16 CATHETER, THE CATHETER BENT WITH THE MANDREL ALSO IN THE VEIN. (PATIENT IN SEVERE PAIN). IS THE INCRIMINATED DEVICE CONTAMINATED WITH A DANGEROUS PRODUCT OR BLOOD? YES. DID YOU COME INTO DIRECT CONTACT WITH BLOOD OR A DANGEROUS PRODUCT DURING THE INCIDENT? NO.

  Patient problems: Pain

  MAUDE report 10429460 ↗
• MalfunctionJul 21, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD INSYTE¿ IV CATHETER 20GA 1.16IN SEPARATED AFTER PLACEMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IV CATHETER SNAPPED OFF IN ARTERY 20G BD INSYTE CANNULA INSERTED TO RADIAL ARTERY BY ANAESTHETIST IN THEATRE PATIENT RETURNED TO WARD, PATIENT STARTED BLEEDING FROM CANNULA SITE. UPON INSPECTION CANNULA APPEARED TO HAVE SNAPPED. TOURNIQUET APPLIED TO STEM BLEEDING PATIENT RETURNED TO THEATRE TO HAVE REMOVED, SURGICAL INCISION AND EXPLORATION OF ARM PERFORMED UNDER GENERAL ANESTHETIC TO TRY AND FIND OTHER END OF CANNULA. SNAPPED OFF PIECE OF CANNULA FOUND IN BANDAGES. PATIENT HAS NUMBNESS IN HAND POST SURGERY. SAMPLE AVAILABLE, BUT ONLY THE HUB OF THE CANNULA".

  Patient problems: Foreign Body In Patient

  MAUDE report 10305933 ↗
• MalfunctionApr 6, 2020Leak/Splash; Device Contamination with Chemical or Other Material; Leak/Splash; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BD INSYTE¿ IV CATHETER 20GA 1.16IN SEPARATED AFTER PLACEMENT AND HAD FLASHBACK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "AFTER THE DEVICE HAS BEEN PLACED, THERE WAS NOT BLOOD REFLUX. REMOVING THE DEVICE THEY SAW THERE WAS THE DISTAL PART OF THE CATHETER MISSING (0,5 CM) AND THE CATHETER WAS DAMAGED. THE MISSING PART HAS BEEN DETECTED BY ECHOGRAPHY IN THE SOFT TISSUE. PATIENT HAS A SURGICAL CONSULTATION BUT IT WAS DECIDED NOT TO REMOVE THE BROKEN PART BECAUSE IT IS INERT IN THE SOFT TISSUE."

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9930574 ↗
• MalfunctionJan 22, 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'S DISTAL END WAS FOUND "FLATTENED" DURING USE AND COULDN'T BE INSERTED. "HEMATOMA" OCCURRED AT THE PUNCTURE SITE AS A RESULT, AND A NEW CATHETER HAD TO BE USED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: "CATHETER DEFECT NOTED DURING USE: THE DISTAL END IS FLATTENED, MAKING IT IMPOSSIBLE TO INSERT THE CATHETER. CONSEQUENCE: HEMATOMA AT THE PUNCTURE SITE. CHANGE OF MATERIAL."

  Patient problems: Hematoma

  MAUDE report 9616033 ↗
• MalfunctionDec 17, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE CATHETER LEAKED DURING USE WITH A BD INSYTE¿ IV CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: LEAK IN THE PERIPHERAL CATHETER WHILE IT IS IN PLACE, DESPITE THE CHANGE OF TUBING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9482317 ↗
• MalfunctionApr 16, 2019Break

  IT WAS REPORTED THAT THE 20G X 1.16IN (1.1 X 30 MM) INSYTE EXPERIENCED PRODUCT DAMAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CATHETER DAMAGED, MATERIAL: 381234, BATCH; 5142297, QUANTITY: 1.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8519605 ↗
• MalfunctionApr 15, 2019Break

  IT WAS REPORTED THAT BEFORE USE OF THE BD¿ INSYTE THE CATHETER WAS DAMAGED. FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: CATHETER DAMAGED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8516482 ↗
• MalfunctionApr 5, 2019Material Puncture/Hole

  IT WAS REPORTED THAT THE CANNULA OF A BD¿ INSYTE WAS PIERCED THROUGH BY CATHETER NEEDLE. FOREIGN COMPLAINTS THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: ¿ WHEN OPENING THE PACKAGE, ONCE THE CATHETER HAS BEEN UNCAPPED, THE NURSE REALIZES THAT THE CANNULA IS TRANSFIXED BY THE CATHETER NEEDLE. THE CATHETER IS NOT USABLE. ¿

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8487810 ↗
• MalfunctionSep 6, 2018Leak/Splash

  IT WAS REPORTED THAT A BD INSYTE¿ IV CATHETER HAD LEAKAGE BETWEEN THE CATHETER AND THE TIP OF THE INFUSION. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7851128 ↗
• InjuryJul 20, 2018Retraction Problem

  IT WAS REPORTED THAT DURING USE OF THE BD INSYTE¿ IV CATHETER THAT THE IV CATHETER DID NOT RETRACT FULLY CAUSING NEEDLE STICK. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

  Patient problems: Needle Stick/Puncture

  MAUDE report 7706983 ↗