BD Insyte Autoguard Shielded IV Catheter 381834Recalls & reported problems
Becton, Dickinson And Company · INSYTE AUTOGUARD PNK 20GA X 1.16IN · Class 2
All models of BD Insyte Autoguard Shielded IV Catheter (4)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This BD Insyte Autoguard shielded IV catheter is a short-term catheter used to start IV lines in a vein. Many of its 398 adverse event reports describe the safety needle not retracting as intended, along with leaks, contamination and catheters breaking or fraying. The reports list 14 injuries and no deaths, including a case where a catheter fragment had to be removed surgically. 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
- 388
- Deaths reported
- 0
- Injuries reported
- 12
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 388 adverse event reports that list this exact device (DI 00382903818341), received between Oct 20, 2017 and Sep 28, 2026 — classified as 12 injuries, 376 malfunctions.
The most frequently reported specific device problem is “Retraction Problem” (134 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 Problem134
- Leak/Splash57
- Device Contamination with Chemical or Other Material43
- Break39
- Material Protrusion/Extrusion15
- Material Puncture/Hole15
- Contamination12
- Device Markings/Labelling Problem11
Patient problems
- No Clinical Signs, Symptoms or Conditions231
- No Known Impact Or Consequence To Patient77
- No Consequences Or Impact To Patient23
- No Patient Involvement15
- Insufficient Information13
- Pain10
- Extravasation7
- No Information7
Recent adverse event reports
The 25 most recent of 388 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Retraction Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922147 ↗MalfunctionSep 15, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50775096 ↗MalfunctionJun 22, 2026Material Puncture/Hole
IT WAS REPORTED THAT THE CATHETER IS UNCOVERED, THE PATIENT IS PUNCTURED, IT IS DIFFICULT TO ENTER THE CATHETER INTO THE SKIN, SINCE ONLY THE NEEDLE ENTERS AND THE PLASTIC PART RETRACTS, SO THE CATHETER IS REMOVED AND THE FLOWERED PLASTIC TIP IS OBSERVED. QUANTITY: 01. TYPE OF DEFECT FOUND: THE PLASTIC PART OF THE CATHETER IS IN BAD CONDITION. ADDITIONAL INFORMATION RECEIVED ON 04 JUN 2026. I COULD SAY YES, SINCE A SECOND PUNCTURE HAD TO BE PERFORMED ON THE PATIENT. DATE OF OCCURRENCE (B)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25575983 ↗MalfunctionJun 17, 2026Retraction Problem
IT WAS REPORTED THAT ¿UPON COMPLETION OF THE VVP INSERTION, THE CANULA DID NOT RETRACT FULLY (APPROXIMATELY 1 CM REMAINED PROTRUDING). I TRIED PRESSING THE BUTTON AGAIN TO RETRACT THE CANULA, BUT IT WOULD NOT RETRACT ANY FURTHER.¿ THE PATIENT DID NOT SUFFER ANY HARM. THE USER DID NOT SUFFER ANY HARM; HOWEVER, SHE NEARLY PRICKED HERSELF WITH THE CANULA USED AND COULD HAVE HAD A BLOOD EXPOSURE INCIDENT. INDEED, THE CANULA IS NORMALLY RETRACTED AFTER APPLYING THE KT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25533373 ↗MalfunctionMay 11, 2026Use of Device Problem; Material Perforation; Material Twisted/Bent
THE INVESTIGATION FINDINGS INDICATE THAT THE NEEDLE PIERCED THE CATHETER. THE CUSTOMER REPORTS THAT THE CATHETER WAS BENT. IT WAS REPORTED THAT WE HAVE RECEIVED SEVERAL COMPLAINTS FROM THE HEALTHCARE TEAM REGARDING THE PERFORMANCE OF THE DEVICE DURING VENIPUNCTURE. ACCORDING TO THE PROFESSIONALS, THE ANGIOCATH HAS PRESENTED DIFFICULTY IN PROGRESSION, WITH FREQUENT REPORTS THAT THE CATHETER ¿BENDS¿ DURING THE PUNCTURE ATTEMPT. THIS SITUATION ENDS UP MAKING VENOUS ACCESS IMPOSSIBLE ON THE FIRST ATTEMPT, RESULTING IN MULTIPLE PUNCTURES IN THE SAME PATIENT. DATE OF IDENTIFICATION OF THE OCCURRENCE; IT OCCURRED ON SEVERAL DAYS. WHEN WAS THE OCCURRENCE WITH THE PRODUCT IDENTIFIED (BEFORE STARTING THE PROCEDURE, DURING HANDLING OF THE PRODUCT BY THE PROFESSIONAL/USER, DURING USE ON THE PATIENT, OR AFTER USE ON THE PATIENT)? DURING USE ON THE PATIENT WAS THERE ANY HARM TO THE PATIENT, HEALTHCARE PROFESSIONAL, USER, OR OTHERS? (PROVIDE DETAILS); IN ADDITION TO DISCOMFORT AND ADDITIONAL RISK TO THE PATIENT, THE PROBLEM HAS GENERATED SIGNIFICANT WASTE OF MATERIALS, SINCE ANGIOCATHS THAT PRESENT THIS COMPLICATION BECOME UNUSABLE, DIRECTLY IMPACTING THE INSTITUTION'S COSTS. WAS MEDICAL AND/OR S
Patient problems: Discomfort
MAUDE report 25138234 ↗MalfunctionMay 11, 2026Retraction Problem
IT WAS REPORTED THAT THE NEEDLE PREMATURELY RETRACTED IN THE UNIT PACKAGE. I RECEIVED THE FOLLOWING REPORT FROM THE EMERGENCY ROOM TEAM: "DEVICE TRIGGERED SAFETY LOCK BEFORE USE, INCLUDING DISCONNECTION OF THE SILICONE, I EMPHASIZE THAT STILL IN THE PACKAGE AND WITHOUT HANDLING". ADDITIONAL INFORMATION RECEIVED ON 04-MAY-2026 IT HAPPENED ON (B)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25137722 ↗MalfunctionApr 23, 2026Leak/Splash; Material Deformation
IT WAS REPORTED THAT THE HUB WAS DAMAGED AND UNABLE TO CONNECT/LEAKED. "THE TUBING DOES NOT FIT THE CATHETER (LEAK). UPON REMOVAL OF THE CATHETER, DEFORMATION IS OBSERVED AT THE SCREW-ON SECTION" UNFORTUNATELY, THE CATHETER HAS NOT BEEN RETAINED" RESPONSE RECEIVED ON:4/17/2026 I CAN CONFIRM THAT THERE HAS BEEN NO HARM TO EITHER THE PATIENT OR THE USER. RESPONSE RECEIVED ON:4/21/2026 I CAN CONFIRM THAT THE EVENT TOOK PLACE ON 16 APRIL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24965769 ↗MalfunctionApr 22, 2026Contamination; Delivered as Unsterile Product
IT WAS REPORTED THAT A HAIR WAS FOUND IN THE CRIMP OF THE MEDICAL DEVICE PACKAGING. RESPONSE RECEIVED ON:04/10/2026: THE EVENT OCCURRED ON 02/04/2026 AND WAS REPORTED TO US ON 6/04.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24954279 ↗MalfunctionMar 30, 2026Detachment of Device or Device Component
THIS MDR IS A RESULT OF AN INVESTIGATION FINDING. IT WAS REPORTED THAT WHEN CUSTOMER TRIED TO REMOVE THE PROTECTIVE CAP FROM THE INSTRUMENT, THE OUTER TUBE WAS STUCK AND ONLY THE INNER TUBE FELL OUT BEFORE USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24714126 ↗MalfunctionFeb 23, 2026Material Protrusion/Extrusion
IT WAS REPORTED THAT THE NEEDLE PIERCED THE CATHETER. WAS THERE ANY DAMAGE TO THE PATIENT'S HEALTH? IF YES, EXPLAIN IN DETAIL. THERE WAS NO DAMAGE. DATE OF EVENT IS NOT CLEARLY DEFINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24415121 ↗MalfunctionFeb 19, 2026Retraction Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24388492 ↗MalfunctionFeb 12, 2026Retraction Problem
NO ADDITIONAL INFORMATION FROM CUSTOMER.
Patient problems: Insufficient Information
MAUDE report 24324844 ↗MalfunctionJan 26, 2026Material Split, Cut or Torn
WHEN THE PATIENT'S IV LINE IS INSERTED, THE CATHETER OPENS. PATIENT IMPACT: NONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24183422 ↗MalfunctionDec 29, 2025Retraction Problem; Retraction Problem
THE CATHETERS THAT WERE NOT ACTIVATING, WE CHECKED WITH THE NURSES IN CHARGE AND FOUND THAT APPROXIMATELY 20 CATHETERS HAD BEEN USED (WITH PROBLEMS) AND WHEN THE SAFETY DEVICE WAS ACTIVATED, IT DID NOT RETRACT THE NEEDLE. THERE IS NO HARM TO PATIENT HEALTH, BUT THERE IS A HIGH RISK OF STAFF INJURY DUE TO THE DEMAND FOR VENIPUNCTURE. I CANNOT GIVE YOU THE EXACT NUMBER, BUT WE HAVE FOUR SHIFTS AND IT WAS HAPPENING DAILY ON ALL FOUR SHIFTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23918150 ↗MalfunctionDec 16, 2025Break; Leak/Splash; Break; Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23821302 ↗MalfunctionDec 16, 2025Retraction Problem; Retraction Problem
SOMETIMES THE NEEDLE IS NOT EVEN RETRACTING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23815962 ↗MalfunctionDec 9, 2025Retraction Problem; Retraction Problem
THE NEEDLE CANNOT RETRACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23761972 ↗MalfunctionNov 24, 2025Material Frayed; Nonstandard Device; Material Frayed; Nonstandard Device
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23640094 ↗MalfunctionNov 4, 2025Retraction Problem; Retraction Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23469669 ↗MalfunctionNov 3, 2025Leak/Splash; Leak/Splash
MalfunctionOct 28, 2025Retraction Problem; Retraction Problem
WHEN THE SAFETY BUTTON IS ACTIVATED, THE NEEDLE DOES NOT RETRACT INTO THE RETRACTION CHAMBER. PLEASE CONFIRM IF THERE HAS BEEN ANY IMPACT TO THE PATIENT. IF YES, EXPLAIN IN DETAIL. A: THERE WAS NO HARM TO THE PATIENT OR THE PROFESSIONAL, ONLY THE RISK OF EXPOSURE TO THE PATIENT'S PERFORATION AND RESIDUE. IT OCCURRED ON (B)(6) 2025, AND I BECAME AWARE OF IT ON THE SAME DATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23410009 ↗MalfunctionOct 16, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED THAT THE N20 INTRAVENOUS CATHETER DID NOT ACTIVATE AND ENDED UP LOSING ACCESS TO THE PATIENT. FAILURE OF THE SAFETY DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23319722 ↗MalfunctionOct 16, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
HARD NEEDLES CANNOT BE RECYCLED. 20 AUG. THE CUSTOMER DOESN¿T RESPOND AND THERE IS NO ADDITIONAL INFORMATION IS AVAILABLE FROM THE CUSTOMER, THANK YOU!
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23316929 ↗MalfunctionOct 15, 2025Contamination; Contamination
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23299919 ↗MalfunctionSep 17, 2025Retraction Problem; Retraction Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23077459 ↗
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-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-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-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-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-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-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-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-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-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-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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