BD Insyte Autoguard 382554Recalls & reported problems
Becton, Dickinson And Company · INSYTE AUTOG BC 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
- 22
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00382903825547), received between Dec 6, 2017 and Mar 12, 2019 — classified as 22 malfunctions.
The most frequently reported specific device problem is “Unsealed Device Packaging” (7 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 Packaging7
- Device Packaging Compromised4
- Degraded3
- Delivered as Unsterile Product3
- Device Disinfection Or Sterilization Issue3
- Loss of or Failure to Bond2
- Retraction Problem2
- Break1
Patient problems
- No Known Impact Or Consequence To Patient17
- No Consequences Or Impact To Patient3
- No Patient Involvement2
Recent adverse event reports
The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 12, 2019Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER HAD FOREIGN MATTER. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. VERBATIM: "BEFORE USING THE CATHETER THE STAFF MEMBER OBSERVED THAT THERE WAS SOME EXTRA VIALON MATERIAL AT THE END OF THE CATHETER. THEY THEN ABANDONED THE CANNULATION AND USED ANOTHER CANNULA."
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8411920 ↗MalfunctionNov 9, 2018Delivered as Unsterile Product
IT WAS REPORTED WITH THE USE OF THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER THERE WAS AN ISSUE WITH STERILE BREACH. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8056610 ↗MalfunctionNov 8, 2018Problem with Sterilization
IT WAS REPORTED WITH THE USE OF THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER THERE WAS AN ISSUE WITH STERILE BREACH. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8052667 ↗MalfunctionNov 8, 2018Delivered as Unsterile Product
IT WAS REPORTED WITH THE USE OF THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER THERE WAS AN ISSUE WITH STERILE BREACH. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8052547 ↗MalfunctionOct 9, 2018Break
IT WAS REPORTED THAT A BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER HAD A BROKEN SEAL. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7947851 ↗MalfunctionSep 14, 2018Loss of or Failure to Bond; Unsealed Device Packaging
IT WAS REPORTED THAT A BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER HAD STERILE BREACH DUE TO PACKAGING ADHESIVE FAILURE. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7878166 ↗MalfunctionJul 25, 2018Delivered as Unsterile Product
IT WAS REPORTED WITH THE USE OF THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER THERE WAS AN ISSUE WITH STERILE BREACH. THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7718327 ↗MalfunctionJul 22, 2018Unsealed Device Packaging
IT WAS REPORTED THAT THE BD INSYTE AUTOGUARD BC SHIELDED IV CATHETERS PACKAGING ADHESIVE FAILED, RESULTING IN A STERILITY BREACH. NOTICED BEFORE USE. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION NOTED.
Patient problems: No Patient Involvement
MAUDE report 7709446 ↗MalfunctionJul 20, 2018Unsealed Device Packaging
IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETERS PACKAGING ADHESIVE FAILED, RESULTING IN A STERILITY BREACH. NOTICED BEFORE USE. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION NOTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7707135 ↗MalfunctionJul 20, 2018Unsealed Device Packaging
IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETERS PACKAGING ADHESIVE FAILED, RESULTING IN A STERILITY BREACH. NOTICED BEFORE USE. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION NOTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7707105 ↗MalfunctionJun 19, 2018Degraded
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 Known Impact Or Consequence To Patient
MAUDE report 7613438 ↗MalfunctionJun 18, 2018Device Disinfection Or Sterilization Issue
IT WAS REPORTED A BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER HAD A STERILE BREACH. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7612392 ↗MalfunctionJun 15, 2018Degraded
IT WAS REPORTED THAT THE PACKAGING OF A BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WAS FOUND DEGRADED AND OPENING SPONTANEOUSLY BREACHING STERILITY. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7607234 ↗MalfunctionJun 14, 2018Device Disinfection Or Sterilization Issue; Device Packaging Compromised
IT WAS REPORTED THAT BEFORE USE A BD INSYTE AUTOGUARD BC SHIELDED IV CATHETER WAS FOUND WITH STERILE BREECH AS "PACKET ADHESIVE APPEARS DEGRADED, PACKETS OPENING SPONTANEOUSLY THEREFORE NO LONGER STERILE." THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION NEEDED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7603010 ↗MalfunctionJun 14, 2018Loss of or Failure to Bond; Degraded; Device Damaged Prior to Use; Device Disinfection Or Sterilization Issue
IT WAS REPORTED THAT THE PACKAGING OF THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER APPEARED TO BE DEGRADED. THE ADHESIVE SEAL IS OPENING SPONTANEOUSLY. THEREFORE, THE PRODUCT IS NO LONGER STERILE. FOUND BEFORE USE. NO REPORTS OF SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.
Patient problems: No Patient Involvement
MAUDE report 7601863 ↗MalfunctionJun 13, 2018Device Packaging Compromised
IT WAS REPORTED THAT BEFORE USE A BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WAS FOUND WITH PACKAGE SEAL INTEGRITY AS"PACKET ADHESIVE APPEARS DEGRADED, PACKETS OPENING SPONTANEOUSLY THEREFORE NO LONGER STERILE."THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION NEEDED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7599030 ↗MalfunctionJun 12, 2018Unsealed Device Packaging
IT WAS REPORTED THAT THE PACKETS OF A BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER(S) WERE ¿OPENING SPONTANEOUSLY¿ AND NO LONGER STERILE. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7592228 ↗MalfunctionMar 5, 2018Device Packaging Compromised
IT WAS REPORTED THAT THE PACKAGING OF THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER ¿PACKAGING IS NOT STICKING PROPERLY AND IS OPENING WITHOUT ANY FORCE REQUIRED.¿ FOUND BEFORE USE. NO REPORTS OF SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7314740 ↗MalfunctionDec 21, 2017Unsealed Device Packaging
IT WAS REPORTED BEFORE USE THAT THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER PACKAGING WAS UNSEALED AND OPEN. NO REPORTS OF SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7140534 ↗MalfunctionDec 7, 2017Unsealed Device Packaging
IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WAS OPENED AND UNSEALED PRIOR TO USE. REPORTS ALSO STATED RETRACTION FAILURE. NO SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7096824 ↗MalfunctionDec 6, 2017Retraction Problem
IT WAS REPORTED THAT THE BD INSYTE AUTOGUARD BC SHIELDED IV CATHETER WAS OPENED AND UNSEALED PRIOR TO USE. REPORTS ALSO STATED RETRACTION FAILURE. NO SERIOUS INJURIES OR MEDICAL INTERVENTION NOTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7089522 ↗MalfunctionDec 6, 2017Retraction Problem; Device Packaging Compromised
IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WAS OPENED AND UNSEALED PRIOR TO USE. REPORTER ALSO STATES RETRACTION FAILURE. NO SERIOUS INJURIES OR MEDICAL INTERVENTION NOTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7089494 ↗
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-1999-2025 · May 21, 2025 · Open, ClassifiedREF: 381423, BD Insyte Autoguard, Shielded IV Catheter, 22GA X 1.00 IN (0.9 X 25 MM) 35mL/min, STERILEEO, RxONLY
- Z-2002-2025 · May 21, 2025 · Open, ClassifiedREF: 381433, BD Insyte Autoguard Shielded IV Catheter, 20GA x 1.00 in (1.1x25 mm) 65 mL/min, STERILEEO, RxOnly
- Z-2003-2025 · May 21, 2025 · Open, ClassifiedREF: 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-2007-2025 · May 21, 2025 · Open, ClassifiedREF: 381434 BD Insyte Autoguard Shielded IV Catheter, 20 GA x 1.16 in (1.1 x 30 mm) 60 mL/min, STERILEEO, RxOnly
- Z-2006-2025 · May 21, 2025 · Open, ClassifiedREF: 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-2000-2025 · May 21, 2025 · Open, ClassifiedREF: 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, ClassifiedREF: 382544 BD Insyte Autoguard Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly
- Z-2001-2025 · May 21, 2025 · Open, ClassifiedREF: 381533, BD Insyte Autoguard Winged, Shielded IV Catheter, 20 GA x 1.00 in (1.1 x 25 mm) 65mL/min, STERILEEO,RxOnly
- Z-2004-2025 · May 21, 2025 · Open, ClassifiedREF: 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-2458-2024 · Jun 26, 2024 · Open, ClassifiedBD 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, ClassifiedBD Insyte Autoguard BC Shielded IV Catheter with Blood Control Technology 20GA X 1.00in, REF: 382533
Other Catheter,intravascular,therapeutic,short-term less than 30 days devices
- BD Insyte Autoguard 382523Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days660 reports
- BD Insyte Autoguard 382533Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days2 recalls527 reports
- BD PosiFlush 306546Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days1 death608 reports
- BD Insyte Autoguard Shielded IV Catheter 381823Becton, Dickinson And Company · Catheter, intravascular, therapeutic, short-term less than 30 days582 reports
- BD Insyte Autoguard 381423Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall528 reports
- BD Insyte Autoguard 382544Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall437 reports
- BD Nexiva, BD Q-Syte 383536Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days2 recalls374 reports
- BD PosiFlush 306547Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days2 recalls1 death331 reports
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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