BD Insyte 381244Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00382903812448), received between Mar 12, 2018 and Feb 24, 2026 — classified as 1 injury, 15 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (6 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 24, 2026Break

  IT WAS REPORTED THAT DURING THE CANNULATION PROCEDURE, THE DEVICE FAILED WHEN IT BROKE IN HALF, PREVENTING IT FROM FUNCTIONING PROPERLY. AS A RESULT, IT HAD TO BE DISCARDED AND REPLACED, REQUIRING THE PATIENT TO BE REPROCESSED. BATCH: 5116410 REF: 381244 IT IS NOTED THAT THE EMERGENCY DEPARTMENT HAS PREVIOUSLY REPORTED DISSATISFACTION WITH THIS PRODUCT. THE REPORT WAS RECEIVED ON JANUARY 29. ADDITIONAL INFORMATION RECEIVED ON 12 FEB 2026 QUANTITIES AFFECTED: ONE (1) UNIT OF THE 18G PERIPHERAL IV CATHETER (CS10-72700302), LOT 5116410, IS CONFIRMED AS AFFECTED. EVIDENCE (PHOTO/VIDEO): A PHOTOGRAPHIC RECORD OF THE DEVICE PACKAGING IS ATTACHED. THERE IS NO IMAGE OF THE DEVICE IN USE. DAMAGE TO PATIENT HEALTH: THERE WAS NO DAMAGE TO THE PATIENT'S HEALTH. THE EVENT WAS IDENTIFIED DURING THE PROCEDURE AND THE DEVICE WAS REPLACED TO CONTINUE CARE. AVAILABILITY OF SAMPLE FOR ANALYSIS: THE SAMPLE IS NOT AVAILABLE BECAUSE THE DEVICE CAME INTO CONTACT WITH THE PATIENT AND WAS DISCARDED IN ACCORDANCE WITH INSTITUTIONAL BIOSAFETY PROTOCOLS. HOWEVER, THE PRODUCT PACKAGING IS RETAINED AND PROVIDED AS EVIDENCE OF THE EVENT. INFORMATION FOR COLLECTION AND REPLACEMENT: SINCE THE DEVICE WAS DISCARDED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24433219 ↗
• MalfunctionFeb 13, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD INSYTE GN 18GA X 1.16IN LEAKED. 67-YEAR-OLD PATIENT TREATED FOR HYPERLEUKOCYTIC ACUTE MYELOID LEUKAEMIA. DURING INSERTION OF A VVP, THE 18G CATHETER FITTED ONTO THE PROXIMAL VALVE OF THE EXTENSION PIECE BUT DID NOT ATTACH CORRECTLY, RESULTING IN A BLOOD LEAKAGE. AFTER SEVERAL ATTEMPTS AND A CHANGE OF EXTENSION PIECE, THE LEAKAGE CONTINUED. THE PATIENT WAS THEREFORE DEPERFUSED AND REPERFUSED WITH A 20G CATHETER, KEEPING THE SAME EXTENSION, AND THE LEAK STOPPED. PATIENT REPERFUSED 2 TIMES WITHOUT NEED (PLATELETS 25 G/L AND HB 8 G/L HAVING BEEN TRANSFUSED SEVERAL TIMES).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21378914 ↗
• MalfunctionOct 15, 2024Material Separation; Material Separation

  MATERIAL # 381244, BATCH # 3328426. IT WAS REPORTED BY CUSTOMER THAT UPON REMOVING CATHETER FROM XXXXX, ABOUT 2/3RDS OF THE CATHETER WAS MISSING. RAN RADIOGRAPHS AND TO FIND IF IT WAS THERE, SENT TO RADIOLOGIST BUT COULD NOT SEE ANYTHING, ADDITIONAL TESTING BUT COULD NOT CONFIRM IT WAS LEFT INSIDE THE PT. VERBATIM: RCC RECEIVED A COMPLAINT VIA PHONE. PIR. VETERINARY: XXX, CONTACT: XXXX, ADDRESS: XXXX, PHONE: XXX, EMAIL: XXX, REF: (B)(4), LOT: 3328426. ISSUE: UPON REMOVING CATHETER FROM XXXXXX, ABOUT 2/3RDS OF THE CATHETER WAS MISSING. RAN RADIOGRAPHS AND TO FIND IF IT WAS THERE, SENT TO RADIOLOGIST BUT COULD NOT SEE ANYTHING, ADDITIONAL TESTING BUT COULD NOT CONFIRM IT WAS LEFT INSIDE THE PT. SAMPLE: YES. REQUESTING SAMPLE RETURN KIT PT HARM: NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20452947 ↗
• MalfunctionSep 27, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT BD INSYTE GN 18GA X 1.16IN CATHETER TIP INTEGRITY AT THE MOMENT OF USING THE CATHETER, THE TIP OF THE CATHETER LOSES ITS SHAPE AND BIFURCATES. IN ONE OF THE TWO PROCEDURES PERFORMED, THE USE OF THIS PART CAUSED DAMAGE TO A VEIN IN THE PATIENT (RUPTURE OF THE VEIN WALL). WE THEREFORE REQUIRE YOUR SUPPORT TO PROCESS THIS COMPLAINT AS A SUSPECTED ADVERSE INCIDENT, WHICH PROCOMSA CLASSIFIES AS LEVEL 1 - MINOR INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20322765 ↗
• MalfunctionAug 5, 2024Contamination; Contamination

  OPENED AND FOUND THAT THE TIP OF THE NEEDLE HAS A RUBBERY FOREIGN BODY, UNUSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19905239 ↗
• MalfunctionJun 4, 2024Leak/Splash; Leak/Splash

  AFTER THE SUCCESSFUL PUNCTURE OF THE INDWELLING NEEDLE, THERE WAS LEAKAGE AT THE CONNECTION BETWEEN THE INNER CORE OF THE INDWELLING NEEDLE AND THE TEE EXTENSION TUBE, AND THE REPLACEMENT OF THE TEE WAS STILL LEAKING, AND IT WAS FOUND THAT THERE WAS A QUALITY PROBLEM IN THE INNER CORE JOINT OF THE INDWELLING NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19461737 ↗
• MalfunctionMay 13, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BD INSYTE GN 18GA X 1.16IN HAD FOREIGN MATTER COMPROMISED STERILITY CONCERN AS UNKNOWN MATERIAL ATTACHED TO SIDE OF CANNULA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19304353 ↗
• MalfunctionMay 9, 2022Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE NEEDLE WAS LOOSE IN THE BD INSYTE¿ IV CATHETER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6): "CATHETER WITHOUT THE PART THAT FIXES THE BEVEL. WHEN CATHETERIZING THE PERIPHERAL ACCESS IN THE PATIENT, THE BEVELED NEEDLE ROTATES."

  Patient problems: Pain

  MAUDE report 14338517 ↗
• MalfunctionFeb 16, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED WHEN USING THE BD INSYTE GN 18GA X 1.16IN, THE DEVICE EXPERIENCED FOREIGN MATTER AT THE TIP OF THE CANNULA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: STAFF WENT TO CANNULATE PATIENT AND NOTICED A FINE THREAD ATTACHED TO THE TIP OF THE CANNULA. ANOTHER CANNULA WAS USED TO CANNULATE PT, HOWEVER STAFF RETAINED THE OTHER CANNULA FOR COLLECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13544630 ↗
• MalfunctionNov 10, 2021Break; Break

  IT WAS REPORTED THAT PART OF THE BD INSYTE¿ IV CATHETER SEPARATED FROM THE HUB WHEN REMOVING THE DRESSING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "STAFF ADVISE THIS IV LUER WAS FOUND LEAKING WHEN IT WAS TO BE REDRESSED. ON REMOVING THE DRESSING IN PLACE THE HUB AND APPROX. 6MM OF THE CANNULA CAME WITH THE DRESSING. THE REMAINDER OF THE CANNULA WAS LUCKILY RETRIEVED QUICKLY, AND THE MEASURE OF THE DEVICE LENGTH INDICATES THE FULL DEVICE HAS BEEN RETRIEVED. IV HAD BEEN IN SITU ONLY 12 HOURS HAVING BEEN PLACED IN (R) HAND IN THEATRE, PRIOR TO AN ELECTIVE PROCEDURE. ANTIBIOTICS, CRYSTALLOID IV FLUIDS AND PHENYLEPHRINE WERE INFUSED THROUGH THE CANNULA. BATCH DETAILS ARE NOT AVAILABLE AS THE DEVICE FAULT WAS FOUND WHEN PATIENT BACK IN THE DEPARTMENT POST OP."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12790852 ↗
• MalfunctionJul 23, 2020Break; Break

  HOLD FOR LJBP 8.21.2020IT WAS REPORTED THAT THE BD INSYTE¿ IV CATHETER TIP TORE DURING THE INSERTION. THIS OCCURRED ON 5 SEPARATE OCCASIONS, BUT THE DATES AND/OR PATIENT INFORMATION ARE UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "INSYTE 18GA TIP TORN DURING INSERTION REPORT RECEIVED TODAY FROM THE CUSTOMER BY PHONE THAT SOME IV CATHS OF INSYTE 18GA WERE TORN ON THE TIP OF THE CANNULAS DURING INSERTION. IT HAPPENS SEVERAL TIMES. PATIENTS COMPLAINED EXCESSIVE PAIN DURING THESE INSERTIONS."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10314442 ↗
• MalfunctionMar 26, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A "PLASTIC TAG" WAS FOUND ON THE BD INSYTE¿ IV CATHETER SHEATH BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PLASTIC TAG ON SHEATH. IT WAS REPORTED THAT THERE WAS A TAG OF PLASTIC THAT STICKS OUT FROM THE PLASTIC SHEATH. THE DR WHO WAS USING THE EQUIPMENT CHECKED THE CANNULA AS THERE IS ANOTHER RECALL IN PLACE, AND OPENED ANOTHER CANNULA WHICH WAS FINE. IT WAS NOT USED ON A PATIENT."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9884183 ↗
• MalfunctionMar 17, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT AN "EXTRA PIECE OF PLASTIC" WAS FOUND ON THE BD INSYTE¿ IV CATHETER BEFORE INSERTING IT INTO THE PATIENT, AND IT "CAME OFF WHEN TOUCHED". LOT#'S 8234059, 9014978, 8082178, AND 9054551 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, EACH WITH 2 OCCURRENCES OF THE EVENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ONE OF OUR DOCTORS NOTICED ON X2 CASES THAT AS HE WAS ABOUT TO INSERT A 18G JELCO THAT THERE WAS AN EXTRA PIECE OF PLASTIC ON THE OUTSIDE OF THE JELCO. THE PLASTIC CAME OFF WHEN TOUCHED. I THINK IT IS A HIGH RISK OF GOING UNNOTICED AND POTENTIALLY BEING INSERTED INTO PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9844759 ↗
• InjuryJun 7, 2019Leak/Splash; Device Contamination with Chemical or Other Material; Leak/Splash; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING USE OF THE INSYTE GN 18GA X 1.16IN WHEN PULLING THE CATHETER OUT PART OF THE CATHETER SHEARED INTO THE PATIENT'S LEG AND WAS UNABLE TO BE REMOVED. AN XRAYS WAS TAKEN OF PATIENT'S LEG AND LUNGS, UNABLE TO REMOVE PIECE SURGICALLY AS IT HAD ALREADY ENTERED THE PATIENT'S (A GREAT DANE) LUNG TISSUE. IT IS EXPECTED TO SCAR OVER AND HAVE NONE TO MINIMAL IMPACT ON THE PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 381244, BATCH NO.: 8110303. IT WAS REPORTED AFTER PULLING OUT THE CATHETER PART OF THE CATHETER SHEARED INTO THE PATIENT'S LEG AND WAS UNABLE TO BE REMOVED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8679124 ↗
• MalfunctionSep 4, 2018Contamination /Decontamination Problem

  IT WAS REPORTED THAT BD INSYTE¿ PERIPHERAL VENOUS CATHETER CONTAINED FOREIGN MATTER DESCRIBED AS "PLASTIC PARTICLES". NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7843720 ↗
• MalfunctionMar 12, 2018Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOREIGN MATTER DESCRIBED AS ¿WHITE RESIDUE¿ WAS FOUND ON A BD INSYTE¿ PERIPHERAL VENOUS CATHETER BEFORE USE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7331288 ↗