BD Insyte 381212Recalls & reported problems

Summary

The FDA's MAUDE database contains 71 adverse event reports that list this exact device (DI 00382903812127), received between Dec 20, 2017 and Mar 25, 2026 — classified as 4 injuries, 67 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (21 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 71 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 25, 2026Nonstandard Device

  THE SECAE FIXATOR IS NOT SUPPOSED TO HAVE ANY FIXATION WITH RESPECT TO THE CATHETER. DURING USE IT WAS REPORTED THAT, RECENTLY SUPPLIED VENOUS CANNULATION CATHETERS HAVE BEEN FOUND TO HAVE A DEFECT THAT COMPROMISES THE SAFETY OF THE PROCEDURE. A DEFECT THAT COMPROMISES THE SAFETY OF THE PROCEDURE. THE CLAMP DOES NOT REMAIN FIRMLY DURING CANNULATION, CAUSING THE CATHETER TO DETACH UNEXPECTEDLY FROM THE CATHETER.

  Patient problems: Insufficient Information

  MAUDE report 24688544 ↗
• MalfunctionJan 6, 2026Break

  NO ADDITIONAL INFORMATION.

  Patient problems: Pain

  MAUDE report 23983302 ↗
• MalfunctionNov 17, 2025Nonstandard Device; Product Quality Problem; Nonstandard Device; Product Quality Problem

  DATE OF OCCURRENCE: (B)(6) 2025. DM REFERENCE: (B)(4). LOT NO.: 5023653. AFTER SUCCESSFULLY INSERTING THE BD INSYTE 24 GA CATHETER, IT IS IMPOSSIBLE TO CONNECT AN EXTENSION TUBE OR VALVE TO THE HUB. THE CATHETER IS REMOVED; THE HUB IS FOUND TO BE DEFORMED. CLINICAL CONSEQUENCES: ANOTHER CATHETER WAS INSERTED INTO THE PATIENT'S OTHER ARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23570771 ↗
• MalfunctionAug 15, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT BD INSYTE YEL 24GA X 0.75IN - 381212 - CATHETER DEFECTIVE / DAMAGED. WHEN SCREWING IN THE BI-DIRECTIONAL VALVE AFTER CATHETER INSERTION (FUNCTIONAL LINE), THE DEVICE JAMS WITHOUT BEING ABLE TO SCREW IN. ADDITIONAL PLASTIC ELEMENT ON THE CATHETER THREAD. BCATHETER CHANGE. REPETITIVE INVASIVE CARE FOR THE SAME CHILD, PAIN AND RISK OF DAMAGING THE VEIN. THE DEVICE HAS NOT PRESERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22816957 ↗
• MalfunctionAug 14, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT BD INSYTE YEL 24GA X 0.75IN 381212 - CATHETER TIP INTEGRITY. REF: 381212. LOT: 4361246, 433038. SWELLING OF THE PLASTIC PREVENTING PASSAGE THROUGH THE VEIN DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22809235 ↗
• MalfunctionAug 14, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT BD INSYTE YEL 24GA X 0.75IN 381212 - CATHETER TIP INTEGRITY. REF: 381212, LOT: 4361246, 433038, SWELLING OF THE PLASTIC PREVENTING PASSAGE THROUGH THE VEIN, DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22809228 ↗
• MalfunctionJan 6, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BD INSYTE 24GX0.75" (0.7X19MM) HAD FOREIGN MATTER ON IT COMPLAINT FROM HONG KONG ADVENTIST HOSPITAL - STUBBS ROAD. THE CUSTOMER COMPLAINED THAT WHEN THE USER PULLED THE NEEDLE OUT OF THE CATHETER, A PLASTIC RESIDUAL FELL OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21079945 ↗
• MalfunctionNov 11, 2024Break; Break

  9-WEEK-OLD INFANT TREATED FOR FEEDING PROBLEMS AND RESPIRATORY DETERIORATION. DURING CATHETER INSERTION, THE CATHETER BROKE TWICE AT THE TOP DURING AN ATTEMPT TO PERFUSE THE PATIENT. CLINICAL CONSEQUENCES : CATHETER NOT INSERTED WITH DOCTOR'S CONSENT. NO OTHER CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20656003 ↗
• MalfunctionNov 10, 2024Defective Component; Defective Component

  ON (B)(6) 2024, IN A PEDIATRIC INTENSIVE CARE UNIT, A PERIPHERAL CATHETER WAS INSERTED WITHOUT DIFFICULTY IN A CHILD. 24 HOURS LATER, WHEN CHANGING THE CATHETER'S FIXATION, THE IDE NOTICED A DIFFUSION OF THE PERFALGAN ADMINISTERED. SHE REMOVED THE CATHETER AND FOUND IT TO BE PIERCED. THERE WERE NO CONSEQUENCES FOR THE PATIENT. THIS IS A RECURRING INCIDENT, DESPITE THE SUPPLIER'S TRAINING OF THE TEAMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20649337 ↗
• MalfunctionNov 8, 2024Material Puncture/Hole; Material Puncture/Hole

  ON (B)(6)2024, DURING THE INSERTION OF A PERIPHERAL VENOUS LINE IN A PAEDIATRIC INTENSIVE CARE UNIT, THE CATHETER WAS PIERCED BY THE MANDREL. A SECOND DEVICE WAS TESTED BY THE NURSE IN ACCORDANCE WITH THE SUPPLIER'S RECOMMENDATIONS, BUT WAS ALSO PIERCED BY THE MANDREL BEFORE INSERTION. THIS IS A RECURRING INCIDENT WITH NO CONSEQUENCES FOR THE PATIENT, DESPITE THE SUPPLIER'S TRAINING OF THE TEAMS. THE DEVICE INVOLVED IN THIS INCIDENT IS AVAILABLE FOR EXPERT EXAMINATION. IN ORDER TO RECOVER IT, PLEASE CONTACT US BY E-MAIL AT THE FOLLOWING ADDRESS: (B)(6) THERE WILL BE A DELAY IN THE PREPARATION OF THE PARCEL (MINIMUM 3 WORKING DAYS), AND IT CAN BE COLLECTED FROM THE FOLLOWING ADDRESS BETWEEN 2 AND 5 PM: (B)(6). I LOOK FORWARD TO RECEIVING YOUR CONCLUSIONS ON THIS INCIDENT AND REMAIN AT YOUR DISPOSAL FOR ANY FURTHER INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20637927 ↗
• MalfunctionSep 11, 2024Defective Device; Defective Device

  (B)(6): 23-AUG-2024. FOLLOW-UP 1ST ATTEMPT SENT ATTACHED THE E-MAIL IN "ATTACHMENT(S)" FIELD BELOW. "1. HAS THERE BEEN ANY HEALTHCARE WORKER¿S EXPOSURE TO BLOOD OR BODILY FLUIDS? ="NO". 2. HAVE ANY OTHER ACTIONS BEEN TAKEN? ="NO". 3. WERE THERE ANY NEGATIVE CONSEQUENCES FOR THE OPERATOR DUE TO THE LEAK OR FOR PATIENTS DUE TO THE MISSED ADMINISTRATION? ="NO". 4. IF YOU HAVE RETAINED A SAMPLE FOR INVESTIGATION, PLEASE PROVIDE US WITH THE PICK-UP ADDRESS (FULL DETAILS ¿ PLEASE USE THE TEMPLATE BELOW). ="WE ONLY HAVE SPECIMENS FROM THE SAME BATCH, NOT THE SAMPLE IN QUESTION.". NAME OF ESTABLISHMENT : "(B)(6)". CITY: "(B)(6)". COLLECTION LINK* : "(B)(6)" COUNTRY : "FRANCE". ADDRESS 1 (STREET, NUMBER): "(B)(6)". CONTACT NAME: "(B)(6) / (B)(6)". ADDRESS 2 (BUILDING, FLOOR, DEPARTMENT) : TELEPHONE NUMBER : "(B)(6)". POSTAL CODE: "(B)(6)". EMAIL ADDRESS: "(B)(6)". *TO ENSURE SMOOTH COLLECTION, WE HIGHLY RECOMMEND LEAVING THE PACKAGE IN AN EASILY ACCESSIBLE LOCATION, SUCH AS MAIN RECEPTION, HOSPITAL PHARMACY OR YOUR GOODS-IN/OUT DEPARTMENT. 5. THE EMPTY SAMPLE SHIPPING BOX WILL BE DELIVERED TO THE SAME ADDRESS. PLEASE ALSO PROVIDE US WITH THE PHONE NUMBER OF A PERSON WHO CAN BE CONTACTED BY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20190058 ↗
• MalfunctionJan 4, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  DISCOVERED BEFORE USE, THERE IS NO CHINESE LABEL ON THE SMALLEST INDIVIDUAL PACKAGE OF THE PRODUCT, THE NUMBER OF AFFECTED 25 PCS, NEED A LETTER OF RESPONSE TO THE COMPLAINT, NEED A LETTER OF ACCEPTANCE OF THE COMPLAINT, NEED A GREEN CLAIM, THE PHOTO CAN NOT BE PROVIDED, THE SAMPLE CAN NOT BE RETURNED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18446389 ↗
• MalfunctionOct 30, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED BD INSYTE YEL 24GA X 0.75IN WAS MISSING LABEL CONTENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER; WHEN THE PRODUCT ARRIVED AT THE HOSPITAL FOR INSPECTION, IT WAS FOUND THAT THE SMALLEST INDIVIDUAL PACKAGE HAD NO CHINESE LABEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18035571 ↗
• MalfunctionSep 15, 2023Material Puncture/Hole; Material Puncture/Hole

  CATHETER OUT OF NEEDLE, THE NEEDLE IS NOT SHARP, HARD TO PUNCTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17760664 ↗
• MalfunctionMay 19, 2023Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE BD INSYTE¿ IV CATHETER EXPERIENCED NEEDLE THROUGH CATHETER WHILE INTRODUCING CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PROBLEM OBSERVED: VERY DIFFICULT TO PRICK THE BABY'S SKIN. ON ONE OF THE CATHETERS, ON REMOVAL, WE NOTICE THAT THE PLASTIC MANDREL IS ALL DAMAGED. WE HAVE THE IMPRESSION THAT WE ARE PRICKING WITH THE PLASTIC GUIDE AND NOT THE NEEDLE: PAIN, FAILURE TO INSERT THE PERIPHERAL VENOUS LINE. ON THE OTHER HAND, THE CATHETER IS EASILY DETACHED FROM THE MANDREL AND ONE IS OBLIGED TO MAINTAIN THE WHOLE TO PRICK THE BABY, KNOWING THAT THE APPROACHES ARE OFTEN COMPLICATED TO FIND AND THAT IT IS NECESSARY TO BE SEVERAL TO HOLD THE BABY. IMMEDIATE ACTION: CHANGE OF THE DEVICE. PATIENT IMPACT: PAIN WHEN INJECTING, FAILURE TO INSERT PERIPHERAL VENOUS LINE PROFESSIONAL IMPACT: FAILURE TO INSERT PERIPHERAL VENOUS LINE, ATTEMPT BY ANOTHER COLLEAGUE.

  Patient problems: Pain

  MAUDE report 16963099 ↗
• MalfunctionMar 29, 2023Material Frayed; Material Frayed

  IT WAS REPORTED THAT 28 BD INSYTE¿ IV CATHETERS WERE FOUND TO BE DAMAGED/FRAYED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PARTIAL BOX OF 50 LNSYTE CATHETERS RETURNED THEIR CUSTOMER REPORTED THAT THEY ARE NOT FEEDING CORRECTLY... THE CATHETERS SENT BACK WOULD NOT FEED INTO THE VEIN AFTER VENIPUCTURE. ALL STAFF PLACING CATHETERS EXPERIENCED THIS, NOT JUST ONE. A DIFFERENT LOT NUMBER WOULD FEED FINE, THIS TOOK PLACE OVER SEVERAL WEEKS (WE DO SURGERY TUES/THURS MORNINGS)AT FIRST IT WAS DISMISSED AS A BAD VEIN DAY/TECHNIQUE BUT OTHER SIZES OR LOT NUMBERS WOULD WORK JUST FINE. I DID LOOK AT A FEW OF THE CATHETER ENDS UNDER THE MICROSCOPE, THEY APPEARED FRAYED? UNFORTUNATELY, SEVERAL PATIENTS HAD SEVERAL LEGS SHAVED TO AID IN EVENTUAL PLACEMENT OF A CATHETER."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16635631 ↗
• MalfunctionMar 1, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE BD INSYTE¿ IV CATHETER THE CANULA OVER NEEDLE WAS DEFORMED. CANULA OVER NEEDLE WAS DEFORMED ¿ THE CANULA WAS PIERCED BY THE NEEDLE AND DEFORMED (THE CANULA WAS BENT WHILE THE NEEDLE WAS STRAIGHT; AS A RESULT OF WHICH THE CANULA WAS PIERCED BY THE NEEDLE). VISUAL INSPECTION OF THE CATHETER/NEEDLE ASSEMBLY REVEALED THE NEEDLE CANNULA PROTRUDING THROUGH THE CATHETER BODY NEAR THE DISTAL TIP. NO DAMAGE WAS NOTED TO THE RETURNED ARTERIAL CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16459161 ↗
• MalfunctionMar 1, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE BD INSYTE¿ IV CATHETER THE CANULA OVER NEEDLE WAS DEFORMED. CANULA OVER NEEDLE WAS DEFORMED ¿ THE CANULA WAS PIERCED BY THE NEEDLE AND DEFORMED (THE CANULA WAS BENT WHILE THE NEEDLE WAS STRAIGHT; AS A RESULT OF WHICH THE CANULA WAS PIERCED BY THE NEEDLE). VISUAL INSPECTION OF THE CATHETER/NEEDLE ASSEMBLY REVEALED THE NEEDLE CANNULA PROTRUDING THROUGH THE CATHETER BODY NEAR THE DISTAL TIP. NO DAMAGE WAS NOTED TO THE RETURNED ARTERIAL CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16459159 ↗
• MalfunctionMar 1, 2023Defective Component; Defective Component

  IT WAS REPORTED THAT THE BD INSYTE¿ IV CATHETER HAD A DAMAGED CANNULA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: ON ONE OF THE CATHETERS, ON REMOVAL, WE NOTICE THAT THE PLASTIC MANDREL IS ALL DAMAGED.

  Patient problems: Pain

  MAUDE report 16458030 ↗
• MalfunctionMar 1, 2023Break; Break

  IT WAS REPORTED THAT THE BD INSYTE¿ IV CATHETER STYLET BROKE FROM THE CANNULA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: ON THE OTHER HAND, THE CATHETER IS EASILY DETACHED FROM THE MANDREL.

  Patient problems: Pain

  MAUDE report 16458029 ↗
• MalfunctionFeb 3, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE NEEDLE PIERCED THROUGH THE BD INSYTE¿ IV CATHETER WHILE INTRODUCING IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "INSYTE 24 KINKING RECEIVED TESTIMONI FROM THE CUSTOMER THERE ARE KINKING DURING USE INSYTE 24 INSERTION"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16299634 ↗
• MalfunctionDec 14, 2022Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE BD INSYTE¿ IV CATHETER NEEDLE WAS LOOSE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE CANNULA WAS NOT FIT WITH THE NEEDLE(VERY LOOSE THAT EFFECTED TO THE CANNULA USUALLY FALL OFF."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15982890 ↗
• MalfunctionDec 14, 2022Defective Component; Defective Component

  IT WAS REPORTED THAT THE BD INSYTE¿ IV CATHETER HOLDER WAS "TOO BIG" AND THE CANNULA WAS "TOO LONG", MAKING IT DIFFICULT TO USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE PART OF HOLDER WAS TOO BIG. THE CANNULA WAS TOO LONG. DIFFICULT TO USE.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15975123 ↗
• MalfunctionNov 15, 2022Break; Break

  IT WAS REPORTED THAT THE TIP OF THE BD INSYTE¿ IV CATHETER BROKE WHEN ADVANCING IT IN THE PATIENT'S VEIN. THIS OCCURRED WITH 3 CATHETERS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT BEFORE THEY PLACE A CATHETER THEY ADVANCE THE STYLETTE ALL THE WAY UP THE CATHETER AND THIS PARTICULAR LOT HAVE BEEN CONSISTENTLY BREAKING AT THE TIP WHEN THEY DO THIS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15799660 ↗
• MalfunctionNov 9, 2022Break; Break

  IT WAS REPORTED WHILE USING BD INSYTE¿, PERIPHERAL IV CANNULA, BD VIALON¿ BIO MATERIAL THE CATHETERS BROKE. THIS OCCURRED TWICE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: 2 CATHETERS BREAK DURING USE CHECK.

  Patient problems: Pain

  MAUDE report 15764565 ↗