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BD Insyte Autoguard 381454Recalls & reported problems

Becton, Dickinson And Company · INSYTE AUTOGUARD GRAY 16GA X 1.16IN · Class 2

All models of BD Insyte Autoguard (33)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
9
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00382903814541), received between Oct 24, 2017 and May 1, 2023 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Unsealed Device Packaging” (4 reports).

11 other recalls cover devices cleared under the same FDA submission (K201075, K251654); they may or may not involve this specific model.

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

Device problems

  • Unsealed Device Packaging4
  • Retraction Problem2
  • Break1
  • Degraded1
  • Material Frayed1
  • Problem with Sterilization1

Patient problems

  • No Consequences Or Impact To Patient4
  • No Known Impact Or Consequence To Patient3
  • No Clinical Signs, Symptoms or Conditions1
  • No Patient Involvement1

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 1, 2023Material Frayed; Material Frayed

    IT WAS REPORTED THAT 10 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETERS' TIPS FRAYED UPON MEETING RESISTANCE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE HAD AN ISSUE OVER THE LAST FEW DAYS WITH 16 GAUGE SHORT IVS BLOWING. WHEN LOOKING AT THEM TODAY THE CATHETER TIP FRAYS EASILY WHEN IT MEETS ANY KIND OF RESISTANCE. THE 16 LONGS AND THE IVS THAT ANESTHESIA USES (THAT DO NOT ALLOW BLOOD RETURN UPON INSERTION) DO NOT HAVE THE SAME ISSUE. ADDITIONAL INFORMATION: I WAS HERE ON WEDNESDAY WHEN WE NOTICED THE ISSUE AND PERSONALLY INSPECTED TWO 16G IVS. THE IV CATHETER TIP IS FRAYING WHEN IT MEETS RESISTANCE WHICH IS CAUSING THE VESSELS TO BLOW DURING INSERTION. WE HAD THIS HAPPEN WITH AT LEAST 10 ON WEDNESDAY."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16841909 ↗
  • MalfunctionAug 26, 2020Break; Break

    IT WAS REPORTED THAT PRIOR TO USE THE CATHETER TIP WAS DISCOVERED TO BE DAMAGED WITH 2 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: THEY REFER FROM THE SERVICE: "PERIPHERAL VENOUS CATHETER # 16 IS UNCOVERED AND IT IS FLOWERED, A NEW CATHETER IS REQUESTED AND IT IS THE SAME." IN TOTAL, TWO CATHETERS WERE IDENTIFIED WITH THE SAME DEFECT.

    Patient problems: No Patient Involvement

    MAUDE report 10457904 ↗
  • MalfunctionDec 3, 2018Problem with Sterilization

    IT WAS REPORTED WITH THE USE OF THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER THERE WAS AN ISSUE WITH STERILE BREACH WITH 10 DEVICES.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8126324 ↗
  • MalfunctionJun 19, 2018Degraded; Unsealed Device Packaging

    IT WAS REPORTED THAT THE SEAL ON A BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER APPEARS DEGRADED, PACKETS OPENING SPONTANEOUSLY THEREFORE NO LONGER STERILE. NO INJURY OR MEDICAL INTERVENTION.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7613400 ↗
  • MalfunctionMay 30, 2018Retraction Problem

    IT WAS REPORTED THAT THE NEEDLE OF A BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER DID NOT COMPLETELY RETRACT, AFTER USE. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7553848 ↗
  • MalfunctionApr 27, 2018Retraction Problem

    RN STARTED 16 GAUGE IV IN PATIENT, PRESSED LOCK TO RETRACT NEEDLE, AND THE NEEDLE DID NOT COMPLETELY RETRACT INTO THE SAFETY HOUSING, LEAVING APPROXIMATELY 1 INCH OF THE NEEDLE INCLUDING THE SHARP END EXPOSED. THE NEEDLE WAS DISPOSED OF IN THE SHARPS CONTAINER, BUT PHOTOGRAPH OF NEEDLE AND PACKAGING WAS CAPTURED. NO HARM CAME TO THE PATIENT OR RN.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7468060 ↗
  • MalfunctionFeb 19, 2018Unsealed Device Packaging

    IT WAS REPORTED BEFORE USE OF THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER ¿THAT THE PACKAGES WERE PREMATURELY OPENING.¿ THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7280876 ↗
  • MalfunctionDec 6, 2017Unsealed Device Packaging

    IT WAS REPORTED THAT THE PACKAGES OF THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER WERE NOT SEALED. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7088856 ↗
  • MalfunctionOct 24, 2017Unsealed Device Packaging

    IT WAS REPORTED THAT THE 16 G X 1.16 IN (1.7 MM X 30 MM) BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER WAS NOT SEALED PROPERLY. FOUND BEFORE USE. NO SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6970854 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K201075, K251654. One submission often covers many models, so check the product and lot details in each record.

  • Z-2000-2025 · May 21, 2025 · Open, Classified
    REF: 382633, BD Insyte Autoguard BC Winged, Shielded IV Catheter with Blood Control Technology, 20GA x 1.00 in (1.1x25 mm) 63 mL/min, STERILEEO, RxOnly
  • Z-2005-2025 · May 21, 2025 · Open, Classified
    REF: 382544 BD Insyte Autoguard Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly
  • Z-1999-2025 · May 21, 2025 · Open, Classified
    REF: 381423, BD Insyte Autoguard, Shielded IV Catheter, 22GA X 1.00 IN (0.9 X 25 MM) 35mL/min, STERILEEO, RxONLY
  • Z-2004-2025 · May 21, 2025 · Open, Classified
    REF: 381811, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly
  • Z-2002-2025 · May 21, 2025 · Open, Classified
    REF: 381433, BD Insyte Autoguard Shielded IV Catheter, 20GA x 1.00 in (1.1x25 mm) 65 mL/min, STERILEEO, RxOnly
  • Z-2007-2025 · May 21, 2025 · Open, Classified
    REF: 381434 BD Insyte Autoguard Shielded IV Catheter, 20 GA x 1.16 in (1.1 x 30 mm) 60 mL/min, STERILEEO, RxOnly
  • Z-2003-2025 · May 21, 2025 · Open, Classified
    REF: 382944, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly
  • Z-2006-2025 · May 21, 2025 · Open, Classified
    REF: 381923 BD Insyte Autoguard Winged Shielded IV Catheter, 22 GA x 1.00 in (0.9 x 25 mm) 35 mL/min, STERILEEO, RxOnly
  • Z-2001-2025 · May 21, 2025 · Open, Classified
    REF: 381533, BD Insyte Autoguard Winged, Shielded IV Catheter, 20 GA x 1.00 in (1.1 x 25 mm) 65mL/min, STERILEEO,RxOnly
  • Z-2458-2024 · Jun 26, 2024 · Open, Classified
    BD Insyte Autoguard BC, Shielded IV Catheter with Blood Control Technology, REF: 382533, 20 GA x 1.00 in (1.1x25 mm) 63 mL/min, Rx Only. BD Insyte Autoguard BC Shielded IV Catheter
  • Z-0400-2024 · Oct 4, 2023 · Open, Classified
    BD Insyte Autoguard BC Shielded IV Catheter with Blood Control Technology 20GA X 1.00in, REF: 382533

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Sources and updates

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