BD Insyte 381247Recalls & reported problems
Becton, Dickinson And Company · INSYTE GN 18GA X 1.88IN · Class 2
All models of BD Insyte (10)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00382903812479), received between Nov 1, 2018 and Mar 31, 2026 — classified as 1 injury, 8 malfunctions.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Device Contamination with Chemical or Other Material5
- Break1
- Leak/Splash1
- Material Separation1
- Retraction Problem1
- Separation Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- Foreign Body In Patient1
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
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? (B)(6) 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 24741652 ↗InjuryFeb 10, 2026Break; Material Separation
DURING ARTERIAL CATHETER INSERTION, THERE WAS NO BLOOD RETURN. UPON WITHDRAWING THE SOFT CATHETER, APPROXIMATELY 2 CM WAS FOUND BROKEN AND RETAINED IN THE BODY. THE LIKELY CAUSE WAS THE PATIENT¿S AGITATION AND FORCEFUL TWISTING DURING THE PROCEDURE, WHICH LED TO CATHETER BREAKAGE.
Patient problems: Foreign Body In Patient
MAUDE report 24305934 ↗MalfunctionJul 9, 2024Leak/Splash; Leak/Splash
THE MEDICAL EXAMINER PRESENTED TO THE RADIOLOGY DEPARTMENT ON (B)(6)2024 10:44 FOR A DIRTY CORONARY CT FOR CARDIOVASCULAR ANGIOGRAPHY, AND WHILE GIVING A VENIPUNCTURE, THE NURSE OBSERVED THAT THE POST-RETURN ORIFICE PLUG IN THE RETRACTOR LUMEN WAS DISLODGED, PREVENTING THE CATHETER FROM BEING ADVANCED IN A TIMELY MANNER, RESULTING IN THE PATIENT'S HEAVY BLEEDING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19698361 ↗MalfunctionOct 13, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT BD INSYTE¿ IV CATHETER 18GA 1.88IN CONTAINED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DURING PREOPERATIVE VENIPECESIS AT 9:00, UNKNOWN FOREIGN MATTER WAS FOUND IN THE INDWELLING NEEDLE HEAD."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12624413 ↗MalfunctionSep 15, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED WHEN USING THE BD INSYTE¿ IV CATHETER THERE WAS FOREIGN MATTER ON THE DEVICE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THERE WAS FOREIGN MATTER AT THE TIP OF NEEDLE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12474604 ↗MalfunctionAug 20, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT 418 BD INSYTE¿ IV CATHETER 18GA 1.88IN EXPERIENCED FOREIGN MATTER IN THE DEVICE CANNULAS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INSYTE.: FOREIGN MATTER ON THE NEEDLE TIP. PROBLEM PRODUCTS: 418.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12346392 ↗MalfunctionJul 30, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT 20 BD INSYTE¿ IV CATHETER NEEDLES HAD FOREIGN MATTER ON THEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "WHEN OPEN THE PACKAGE, THERE WAS FOREIGN MATTER ON THE NEEDLE POINT."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12255326 ↗MalfunctionOct 28, 2020Retraction Problem; Retraction Problem
IT WAS REPORTED THAT THE INSYTE GN 18GA X 1.88IN NEEDLE WOULDN'T RETRACT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "AFTER INSERTING, CATHETER KINKING AND CAN¿T DRAW OUT NEEDLE"
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10752539 ↗MalfunctionNov 1, 2018Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT BD INSYTE¿ IV CANNULA WITH BD VIALON¿ BIOMATERIAL CONTAINED FOREIGN MATTER. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8029942 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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