Insyte Autoguard 381833Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00382903818334), received between Oct 12, 2022 and Apr 30, 2026 — classified as 2 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Retraction Problem” (6 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 18, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 30, 2026Material Integrity Problem

  IT WAS REPORTED THAT THE CATHETER TIP HAD A BULGE. OUR ED STAFF IS HAVING TROUBLE WITH ALL IV CATHETERS WITH THIS LOT #. THEY ARE HAVING TROUBLE ADVANCING THE CATHETER AFTER THE INITIAL PUNCTURE OF THE VEIN, SOME NOT ABLE TO ADVANCE AND BLOWING THE VEIN. AFTER INSPECTION, SEVERAL STAFF BELIEVE THERE IS A SLIGHT BULGE NEAR THE TIP OF THE VIALON CATHETER THAT IS ABNORMAL AND MAY CONTRIBUTE TO THE DIFFICULTY ADVANCING.

  Patient problems: Perforation of Vessels

  MAUDE report 25045754 ↗
• MalfunctionDec 14, 2025Retraction Problem; Retraction Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: Perforation of Vessels

  MAUDE report 23799443 ↗
• MalfunctionOct 24, 2025Retraction Problem; Retraction Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23376310 ↗
• InjuryAug 7, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  EVENT DETAILS: AN EMERGENCY ROOM NURSE ALERTED ME TODAY TO THE PRESENCE OF A FOREIGN BODY, PRESUMABLY A SMALL PIECE OF HARD PLASTIC ON THE OUTSIDE OF THE CATHETER ADAPTER OF A SHORT AUTOGUARD 20G 25MM KT REF 381833, LOT 4310283, WHICH SHE SAW WHILE PUSHING THE KT INTO A PATIENT'S VEIN. SHE IMMEDIATELY REMOVED THE KT. THIS SMALL PIECE (WHICH SHE CALLS A ¿SPANGLE¿ IN HER STATEMENT) FELL TO THE FLOOR AS THE KT WAS WITHDRAWN. WITH OTHER COLLEAGUES, SHE OPENED A DOZEN OTHER KTS FROM THE SAME BATCH AND FOUND A SIMILAR SMALL PIECE ON A 2ND KT THAT I RECOVERED AND VISUALIZED. AS NO OTHER BATCH OF THIS SIZE WAS AVAILABLE IN THE PHARMACY, I WAS UNABLE TO QUARANTINE THIS BATCH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22745441 ↗
• InjuryMar 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT BD INSYTE AUTOGUARD POSSIBLE IV SITE INFECTION IN THE PRESENCE OF OTHER INFECTIOUS PROCESSES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: ¿DATE OF EVENT: (B)(6) 2025, EQUIPMENT CONCERNED: BD INSYTE AUTOGUARD MODEL: 381833 LOT :4310283 PER: (B)(6) 2027 PROBLEM ENCOUNTERED: AFTER REMOVAL OF CATHETER, WOUND AND PAIN WITH INFLAMMATORY INDURATION OF A PATIENT. ACTION TAKEN: ALCOHOL AND WATER COMPRESS ON THE WOUND. ATYPICAL TREATMENT, ANTIBIOTIC. PATIENT IMPACT: INFLAMMATORY PAIN FEVER THE DEVICE IS NOT AVAILABLE PHOTO AND DOCTOR'S DESCRIPTION ATTACHED¿ ATTACHED IS AN INFECTION FOLLOWING A PERIPHERAL CATHETER INSERTED IN SMR ON (B)(6) 2025 AT 12 NOON BEFORE A COLONOSCOPY SCHEDULED FOR THE AFTERNOON. THE PATIENT WAS VOMITING AND IS DIABETIC. THE CATHETER WAS REMOVED THE SAME EVENING AFTER THE EXAMINATION. IN THE WEEKEND (B)(6) THAT FOLLOWED THE APPEARANCE OF PAIN WITH INFLAMMATORY INDURATION, COMPRESS ALCOHOL AND WATER APPLIED. ON MONDAY (B)(6) NOTICED THIS, PATIENT HAD COVID + FEVER. TREATED BY AUGMENTIN. NO MAJOR BIOLOGICAL INFLAMMATORY SYNDROME: 36 ON (B)(6) AND 46 ON (B)(6). APYRETIC SINCE (B)(6).

  Patient problems: Pain; Skin Inflammation/ Irritation

  MAUDE report 21711035 ↗
• MalfunctionOct 9, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20413234 ↗
• MalfunctionOct 4, 2024Fluid/Blood Leak; Fluid/Blood Leak

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20371209 ↗
• MalfunctionOct 4, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BD INSYTE AUTOGUARD FOREIGN MATTER FOUND ON NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH DATE OF OCCURRENCE: ON (B)(6) 2024. INCIDENT DESCRIPTION: WHILE HANDLING THE MANDREL, A SUSPICIOUS BLACKENING WAS SPOTTED ON THE CANULA AS WELL AS ON THE CATHETER ADAPTER. CURRENT PATIENT CONDITION: NO DIRECT CONSEQUENCES FOR THE PATIENT, PROBLEM IDENTIFIED BEFORE USE. RISK OF IATROGENIA IF CONTAMINATION OF THE BATCH IS CONFIRMED. ACTIONS TAKEN IN THE CARE FACILITY TO MANAGE THE PATIENT: USE OF ANOTHER DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20367440 ↗
• MalfunctionJan 16, 2024Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETERS' NEEDLE WAS DID NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ONCE I FINISHED INSERTING THE IV, I WENT TO PUSH THE BUTTON FOR THE NEEDLE RETRACTION AND THE BUTTON DIDN'T DEPRESS AND THE NEEDLE DID NOT RETRACT. I OBSERVED THERE WAS NO OBVIOUS DEFECT OF THE NEEDLE OR THE REST OF THE DEVICE. THE DEVICE WAS THE INSYTE AUTOGUARD SHIELDED IV CATHETER 20G. THE NEEDLE NOT RETRACTING PUT ME AT A POTENTIAL RISK THAT DID NOT HAPPEN, ONCE I REALIZED THE DEVICE WAS DEFECTIVE, I PLACED THE NEEDLE ON THE FLOOR AWAY FROM ME AND THE PATIENT UNTIL I COMPLETED THE IV INSERTION AND PLACED THE NEEDLE INTO THE SHARPS CONTAINER PROMPTLY FOLLOWING THE TASK. EXPOSED NEEDLE. NO HARM TO THE PATIENT OCCURRED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18521251 ↗
• MalfunctionDec 21, 2023Retraction Problem; Retraction Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18371196 ↗
• MalfunctionDec 12, 2023Retraction Problem; Component Missing; Retraction Problem; Component Missing

  IT WAS REPORTED THAT BD INSYTE AUTOGUARD HAD A NEEDLE RETRACTION PROBLEM WITH REPORT OF A MISSING SPRING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: A 3AP NURSE WAS INJURED ON FRIDAY, (B)(6) 2023, WHILE ACTIVATING THE SAFETY OF A PERIPHERAL VENOUS CATHETER. SHE HELD THE CATHETER BETWEEN HER THUMB AND FOREFINGER. WHEN SHE ACTIVATED THE SECURITY, BY PRESSING THE WHITE BUTTON WITH HER THUMB, SHE FELT A STING ? A PINCH ? AT THE INDEX LEVEL. WHEN SHE LOOKED AT THE DEVICE AND COMPARED IT WITH ANOTHER DEVICE SHE HAD JUST OPENED, SHE NOTICED THAT A PIECE OF THE PLASTIC PART PROTECTING THE SPRING WAS MISSING. THE NURSE DID NOT KEEP THE OFFENDING CATHETER. IT WAS A BD INSYTE AUTOGUARD 20 GA REF 381833. CURRENTLY, DEVICES FROM THE LOT 3055420 EXPIRY DATE 2026-02-28 ARE USED IN THE SERVICE. CONSEQUENCES : NO WOUND A PRIORI BUT POTENTIAL RISK OF EXPOSURE TO THE PATIENT'S BLOOD LOCATION OF THE DEVICE : NOT PRESERVED, NOT AVAILABLE FOR EXPERTISE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18313295 ↗
• MalfunctionDec 6, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BD INSYTE AUTOGUARD HAS FOREIGN MATTER INSIDE THE CAP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 1. PLEASE DESCRIBE THE SPECIFIC ISSUE FOUND ON DEFECTIVE PRODUCT? BLACK SPECS NOTED INSIDE THE CAP OF THE NEEDLE UPON OPENING A NEW ANGIOCATH 2. HOW WAS THE PATIENT OUTCOME? ARE THERE ANY CLINICAL SIGNS, HEALTH CONSEQUENCES OR IMPACT? NO IMPACT TO PATIENT, THE PRODUCT WAS SWITCHED TO A NEW ANGIOCATH AFTER CAREFUL INSPECTION. 3. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTH CARE PROFESSIONAL? NO 4. ARE YOU ABLE TO PROVIDE THE DATES OF THE EVENTS IN THE FORMAT OF MM-DD-YYYY? IF UNKNOWN, CAN STATE UNKNOWN.(B)(6) 2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18279662 ↗
• MalfunctionOct 12, 2022Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ IV CATHETER NEEDLE WOULD NOT RETRACT WHEN THE SAFETY DEVICE BUTTON WAS PRESSED. THIS OCCURRED WITH 5 CATHETERS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE: "I REPORT 5 CASES OF CATHETER NUMBER 20 THAT DID NOT WORK SAFETY VALVE TO PROTECT THE NEEDLE. NURSING ACTIVATES THE WHITE BUTTON AND DOES NOT TRIGGER THE SAFETY DEVICE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15588016 ↗