BD Insyte-N Autoguard 381411Recalls & reported problems
Becton, Dickinson And Company · INSYTE-N AUTOGUARD YEL 24GA X .56IN · Class 2
All models of BD Insyte-N Autoguard (4)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This BD Insyte-N Autoguard IV catheter is a short-term tube placed in a vein to give fluids or medicines. Some reports describe the needle not retracting into its safety shield, and others describe catheters that shred, split or leak. The 155 reports include no deaths and 10 injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 154
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 154 adverse event reports that list this exact device (DI 00382903814114), received between Oct 3, 2017 and Jun 8, 2026 — classified as 10 injuries, 144 malfunctions.
The most frequently reported specific device problem is “Retraction Problem” (36 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.
Reports received per month
Most reported problems
Device problems
- Retraction Problem36
- Leak/Splash23
- Material Split, Cut or Torn22
- Device Contamination with Chemical or Other Material13
- Material Frayed10
- Break8
- Defective Component8
- Material Integrity Problem8
Patient problems
- No Clinical Signs, Symptoms or Conditions109
- No Known Impact Or Consequence To Patient21
- Insufficient Information14
- Needle Stick/Puncture4
- Discomfort3
- No Code Available3
- Device Embedded In Tissue or Plaque2
- Bacterial Infection1
Recent adverse event reports
The 25 most recent of 154 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 8, 2026Material Frayed
FOUR DIFFERENT ACCOUNTS THE BD INSYTE CATHETER FOR IV INSERTION 24 G SHREDDED WHILE ATTEMPTING IV START IN THE NICU PLEASE PROVIDE AN EXACT DATE OF EVENT: 5/15/26 DESCRIBE ANY PATIENT¿S HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25436166 ↗MalfunctionJun 8, 2026Material Frayed
FOUR DIFFERENT ACCOUNTS THE BD INSYTE CATHETER FOR IV INSERTION 24 G SHREDDED WHILE ATTEMPTING IV START IN THE NICU PLEASE PROVIDE AN EXACT DATE OF EVENT: (B)(6) 2026 DESCRIBE ANY PATIENT¿S HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25436165 ↗MalfunctionJun 8, 2026Material Frayed
FOUR DIFFERENT ACCOUNTS THE BD INSYTE CATHETER FOR IV INSERTION 24 G SHREDDED WHILE ATTEMPTING IV START IN THE NICU PLEASE PROVIDE AN EXACT DATE OF EVENT: 5/15/26. DESCRIBE ANY PATIENT¿S HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25436161 ↗MalfunctionMay 15, 2026Product Quality Problem
IT WAS REPORTED THAT THE NEEDLE HUB HAD A SHARPNESS. "CUSTOMER PLACED 24 X 0.75 PIVC IN XXX PATIENT - CORRECT PROCESS AND PROCEDURE WAS FOLLOWED. CUSTOMER MENTIONED THAT THERE WAS A PRESSURE WOUND FROM BD PIVC AS THERE WAS A SHARPNESS ON THE CATHETER HUB.".
Patient problems: Unspecified Skin and Subcutaneous Tissue Problem
MAUDE report 25184569 ↗MalfunctionApr 30, 2026Leak/Splash; Material Puncture/Hole
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25044845 ↗MalfunctionApr 22, 2026Material Puncture/Hole
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24955100 ↗MalfunctionApr 13, 2026Retraction Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24865227 ↗MalfunctionApr 13, 2026Use of Device Problem; Material Split, Cut or Torn
IT WAS REPORTED THAT THE NEEDLE PIERCED THE CATHETER. "WHILE ATTEMPTING AN IV INSERTION, ALL FOUR IV CATHETERS USED HAD THE NEEDLE GO THROUGH THE PLASTIC CATHETER WHILE IT WAS BEING INSERTED INTO PATIENT. NO CATHETER FRAGMENTS WERE LEFT BEHIND UNDER THE SKIN, BUT THE NEEDLE CONSISTENTLY WENT THROUGH THE CATHETER WHILE TRYING TO THREAD THE NEEDLE. BREAKING OF THE PLASTIC CATHETER REQUIRED MORE UNNECESSARY ATTEMPTS AT GAINING IV ACCESS ON THE PATIENT.¿ ADDITIONAL INFORMATION 4/10/2026: QUESTION: DID ALL 4 REPORTED OCCURRENCES OF NEEDLE THROUGH CATHETER HAPPEN WITH THE SAME PATENT ON THE SAME DAY? IF NO, PLEASE PROVIDE THE NUMBER OF AFFECTED PATIENTS AND DATES OF EVENTS. REPLY: NICU LEADERSHIP HAS DETERMINED THIS IS AN EDUCATIONAL OPPORTUNITY FOR STAFF. NURSES ARE DISENGAGING THE CATHETER FROM THE NEEDLE AND PLACING BACK TO ORIGINAL POSITION PRIOR TO STICKING PATIENT. THIS IS A DATED PRACTICE THAT OCCURRED WITH OUR PREVIOUS CATHETERS BECAUSE THE HUB WOULD NOT DISENGAGE ONCE THE IV WAS PLACED, AND WE ARE FINDING IT IS CONTINUING. WE WILL WORK WITH OUR EDUCATION TEAM TO PASS ALONG TO STAFF APPROPRIATE TECHNIQUE. I WILL REACH OUT IF I NEED ANY ADDITIONAL RESOURCES FOR THE EDUCATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24860041 ↗MalfunctionApr 7, 2026Material Puncture/Hole
CUSTOMER RESPONSE ON 07-APR-2026. PLEASE CLOSE THIS INCIDENT. IT HAS ALREADY BEEN RESOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24802275 ↗MalfunctionApr 7, 2026Material Puncture/Hole
CUSTOMER RESPONSE ON 07-APR-2026. PLEASE CLOSE THIS INCIDENT. IT HAS ALREADY BEEN RESOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24802274 ↗MalfunctionApr 6, 2026Material Split, Cut or Torn
IT WAS REPORTED THAT THE CATHETER SPLIT. "TWO DIFFERENT 24G IV CATHETERS SPLIT AT THE PLASTIC SHEATH UPON INSERTION INTO SKIN. A THIRD CATHETER WAS USED WITH A DIFFERENT LOT NUMBER NO COMPLICATIONS.".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24792443 ↗MalfunctionApr 2, 2026Contamination /Decontamination Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24769581 ↗MalfunctionApr 1, 2026Activation, Positioning or Separation Problem
IT WAS REPORTED THAT THE NEEDLE WOULD NOT RETRACT. WOULD NOT RETRACT NEEDLE WHEN TRYING TO DISENGAGE (SAFETY MECHANISM DEFECTIVE).
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24758367 ↗MalfunctionMar 30, 2026Material Integrity Problem
NO NEW INFORMATION.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24716623 ↗MalfunctionMar 30, 2026Material Integrity Problem
ADDITIONAL INFORMATION: 30-MAR-2026: THERE WAS NOT HARM TO THE PATIENTS OTHER THAN REQUIRING AN ADDITIONAL POKE TO OBTAIN PERIPHERAL ACCESS.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24715998 ↗MalfunctionMar 30, 2026Material Integrity Problem
ADDITIONAL INFORMATION: 30-MAR-2026: THERE WAS NOT HARM TO THE PATIENTS OTHER THAN REQUIRING AN ADDITIONAL POKE TO OBTAIN PERIPHERAL ACCESS.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24715795 ↗MalfunctionMar 30, 2026Material Integrity Problem
ADDITIONAL INFORMATION: 30-MAR-2026: THERE WAS NOT HARM TO THE PATIENTS OTHER THAN REQUIRING AN ADDITIONAL POKE TO OBTAIN PERIPHERAL ACCESS.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24715733 ↗MalfunctionFeb 4, 2026Material Split, Cut or Torn
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24261921 ↗MalfunctionFeb 4, 2026Material Split, Cut or Torn
WE HAVE SEVERAL CATHETERS THAT WERE SHREDDED ADDITIONAL INFORMATION RECEIVED: PLEASE PROVIDE AN EXACT DATE OF EVENT. 01/20/2026 IS WHEN THE EVENT HAPPENED DESCRIBE ANY PATIENT¿S HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24261903 ↗MalfunctionJan 23, 2026Retraction Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24166886 ↗MalfunctionDec 29, 2025Material Frayed; Material Frayed
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23918170 ↗MalfunctionDec 8, 2025Break; Break
CUSTOMER STATES THAT THEY HAVE HAD 3 INSYTE AUTOGUARD NEEDLES SPLIT WHILE USING ON PATIENTS. NO PATIENT HARM. ON (B)(6) 2025: WHEN I REACHED OUT TO, REGARDING THE REPORTS SHE SUBMITTED, I INFORMED HER THAT WE LOGGED TO CAPTURE SIMILAR FAILURES REPORTED BY YOU AND ASKED IF HER REPORTS WERE RELATED TO THE SAME EVENT OR SEPARATE EVENTS. SHE CONFIRMED THEY WERE SEPARATE ISSUES ON (B)(6) 2025: WORKS FOR ME AND I AM CONFIRMING THAT THE EVENTS SHE REPORTED ARE TWO SEPARATE EVENTS WITH TWO SEPARATE SAFE REPORTS. WHAT I AM REFERRING TO IN OUR ONGOING INVESTIGATION ARE REFERENCING THE TWO EVENTS PREVIOUSLY REPORTED. YOU HAVE ALL THE INFORMATION REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23745101 ↗MalfunctionDec 8, 2025Break; Break
CUSTOMER STATES THAT THEY HAVE HAD 3 INSYTE AUTOGUARD NEEDLES SPLIT WHILE USING ON PATIENTS. NO PATIENT HARM. (B)(6) 2025: WHEN I REACHED OUT TO REGARDING THE REPORTS SHE SUBMITTED, I INFORMED HER THAT WE LOGGED TO CAPTURE SIMILAR FAILURES REPORTED BY YOU AND ASKED IF HER REPORTS WERE RELATED TO THE SAME EVENT OR SEPARATE EVENTS. SHE CONFIRMED THEY WERE SEPARATE ISSUES (B)(6) 2025: WORKS FOR ME AND I AM CONFIRMING THAT THE EVENTS SHE REPORTED ARE TWO SEPARATE EVENTS WITH TWO SEPARATE SAFE REPORTS. WHAT I AM REFERRING TO IN OUR ONGOING INVESTIGATION ARE REFERENCING THE TWO EVENTS PREVIOUSLY REPORTED. YOU HAVE ALL THE INFORMATION REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23745079 ↗MalfunctionDec 8, 2025Break; Break
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23745075 ↗MalfunctionNov 10, 2025Defective Component; Material Integrity Problem; Defective Component; Material Integrity Problem
REPORTED ISSUE: IV CATHETER SHREDDED UPON INSERTION. INJURIES OR ADVERSE EVENT: NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23514199 ↗
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, 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-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-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-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-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-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-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-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-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-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.
How reports and recalls are matched · Editorial policy · Report an error on this page