BD Introsyte-N Autoguard, BD Instaflash 384008Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00382903840083), received between Jun 28, 2019 and Dec 4, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 4, 2025Leak/Splash; Leak/Splash

  ADDITIONAL INFORMATION RECEIVED. THIS MDR IS BEING CANCELLED DUE TO CLARIFYING INFORMATION RECEIVED FROM THE CUSTOMER. PRODUCT CONFIRMED TO BE NOT A BD PRODUCT COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23720343 ↗
• MalfunctionDec 13, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20924931 ↗
• MalfunctionDec 13, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  MATERIAL#: 384008, BATCH#: 4087754. IT WAS REPORTED BY THE CUSTOMER THAT DURING THE PROCESS OF "BREAKING AWAY", THE CATHETERS HAVE SPLIT ASYMMETRICALLY, MAKING IT IMPOSSIBLE TO REMOVE THE INTRODUCER WITHOUT ALSO REMOVING THE ENTIRE LINE AND HAVING TO BEGIN THE ENTIRE PROCEDURE AGAIN RCC RECEIVED A COMPLAINT VIA EMAIL. BD INTROSYTE-N AUGTOGUARD 26 GA, REF: 384008. LOT: 4087754. NO INJURIES OR SERIOUS HARM. ON THREE OCCASIONS, DURING THE PROCESS OF "BREAKING AWAY" THE CATHETERS HAVE SPLIT ASYMETRICALLY, MAKING IT IMPOSSIBLE TO REMOVE THE INTRODUCER WITHOUT ALSO REMOVING THE ENTIRE LINE AND HAVING TO BEGIN THE ENTIRE PROCEDURE AGAIN. ADDITIONAL INFORMATION RECEIVED ON 04-DEC-2024: THANKS FOR YOUR RESPONSE. TWO OCCURRENCES WERE WITH DIFFERENT PATIENTS. THE THIRD WAS WHILE WE WERE TRYING TO REPLICATE THE PROBLEM IN AN OFFICE ENVIRONMENT. WE ONLY HAVE THE TWO DEVICES SAVED THAT WERE IN USE WITH PATIENTS. THE DATES OF THE EVENTS WERE 11/29/24 AND 12/1/2024. THE CAREGIVERS INVOLVED WERE TWO DIFFERENT PEOPLE AND THE PATIENTS WERE ALSO TWO DIFFERENT PEOPLE. WE WILL LABEL THE DEVICES WE ARE SENDING YOU WITH THE DATES OF THE EVENTS. THE ORIGINAL PACKAGING WITH THE LOT NUMBER WAS SAVED FROM THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20924900 ↗
• MalfunctionApr 24, 2023Break; Break

  IT WAS REPORTED THAT THE INTROSYTE AUTOGUARD 26G INTRO ONLY SHEATH BROKE OFF COMPLETELY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AS I WENT TO PEEL THE SHEATH, ONE SIDE OF THE SHEATH BROKE OFF COMPLETELY RIGHT AT THE PURPLE PART OF THE INTRODUCER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16802284 ↗
• MalfunctionAug 27, 2021Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT THE INTROSYTE AUTOGUARD 26G INTRO ONLY WINGS BROKE OFF WHILE REMOVING THE SHEATH DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE RN WAS ATTEMPTING TO INSERT A PICC LINE. AFTER THE THIRD ATTEMPT, SHE WAS SUCCESSFUL. WHEN BLOOD RETURN NOTED AND INSERTED THE CATHETER, SHE BROKE THE WINGS OF THE INTRODUCER TO REMOVE THE SHEATH. THE WINGS BROKE OFF AND LEFT THE SHEATH ON THE CATHETER. SHE ATTEMPTED TO REMOVE THE SHEATH USING HEMOSTATS WHICH WAS UNSUCCESSFUL, SO SHE HAD TO REMOVE THE LINE. THEY WILL HAVE TO ATTEMPT TO INSERT A PICC LATER ON."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12380708 ↗
• MalfunctionJan 8, 2021Break; Break

  IT WAS REPORTED THAT THE INTROSYTE AUTOGUARD 26G INTRO ONLY SHEATH DID NOT SPLIT AS INTENDED DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE RECEIVED A DEFECTIVE LOT OF PERIPHERAL INSERTED CENTRAL CATHETER. A PIECE OF THE ITEM BROKE OFF OF THE CATH INTO A PATIENT. " "TO CLARIFY: THE DEVICE THAT FAILED WAS NOT RETAINED IN THE PATIENT. ITS FAILURE WOULD BE BETTER DESCRIBED AS THE CATHETER WOULD NOT PEEL APART AS DESIGNED. THE PICC INSERTION TEAM HAD A CHOICE (AND WENT WITH OPTION 3 ¿ IT EVENTUALLY WORKED): 1. REMOVE THE NEWLY INSERTED INFANT PICC LINE 2. CUT THE BULK OF THE INSERTION CATHETER AND LEAVE IT ENCAPSULATING THE PICC LINE, SECURING IT DISTALLY (NEAR THE HUB) 3. PICK AT THE INSERTION CATHETER AND TRY TO GET IT TO SEPARATE AND LIFT OFF THE PICC LINE WITHOUT DAMAGING THE PICC LINE." " I CAN CONFIRM THAT IT WAS NOT THE PICC THAT FAILED, IT WAS THE PEEL AWAY INTRODUCER. UNFORTUNATELY WE DID NOT RETAIN THE CORRECT DEVICE PACKAGING, THEREFORE I CANNOT GUARANTEE THE LOT NUMBER OF THE DEVICE. HOWEVER IT IS HIGHLY PROBABLE THAT IT MATCHES THE LOT # OF THE DEVICE SHOWN IN THE PHOTO B

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11143487 ↗
• MalfunctionJan 4, 2021Break; Fluid/Blood Leak

  NEOPICC ASSESSED, NOTICED FLUID LEAKING AROUND THE PATIENT, INSPECTED LINE AND FOUND SMALL BREAK, NURSE PRACTITIONER REMOVED NEOPICC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11114027 ↗
• MalfunctionJul 3, 2019Break; Material Separation; Break; Material Separation

  MATERIAL NO.: 384008 BATCH NO.: 8297893. IT WAS REPORTED THAT DURING USE OF THE BD INTROSYTE-N AUTOGUARD SHIELDED INTRODUCER THE INTRODUCER TORE AND BROKE WHILE TRYING TO PEEL IT APART. THE CENTRAL LINE WAS REINSERTED. THE INCIDENT OCCURRED ON (B)(6) 2019. BABY GIRL, 2 DAYS OLD. PICC LINE PLACED AT LEFT ANTECUBITAL. WHEN TRYING TO REMOVE THE INTRODUCER OFF OF THE LINE ONE OF THE PURPLE PIECES BROKE OFF MAKING IT IMPOSSIBLE TO GET THE INTRODUCER SHEATH OFF OF THE LINE. LINE HAD TO BE PULLED OUT AND BABY RE-STUCK AGAIN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8760194 ↗
• MalfunctionJun 28, 2019Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A BREAKAGE OCCURRED DURING USE WITH A 26G (1.9 FR) X 1.9 CM BD INTROSYTE-N AUTOGUARD SHIELDED INTRODUCER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, I RECEIVED A RISK MASTER FROM NICU REGARDING A BD 26 GAUGE INTROSYTE-N AUTOGUARD SHIELDED INTRODUCER. IT STATES THAT THE INTRODUCER TORE AND BROKE WHILE TRYING TO TEAR IT APART. THEY WERE UNABLE TO GET THE INTRODUCER OFF AND HAD TO PULL THE PICC OUT AND RESTICK. CAN YOU HOOK ME UP WITH THE PERSON I SHOULD REPORT THIS TO AT BD? THIS HAS HAPPENED A FEW TIMES SINCE FEBRUARY. THANK YOU." PER PHONE CALL: SPECIFIED THAT THE PRODUCT # 384008 AND LOT # 8297893 WAS THE AFFECTED DEVICE. SHE DID NOT HAVE ANY SPECIFIC DATES OR PATIENT INFO IN THEIR SYSTEM AND HAD JUST HEARD ABOUT THE PAST ISSUES VIA WORD OF MOUTH FROM THE NURSES. NO ISSUES OR HARM JUST HAD TO RESTICK THE INFANT. SHE HAS THE BROKEN DEVICE AND CAN SEND IT BACK." 1 OF 2 COMPLAINTS.

  Patient problems: Injury

  MAUDE report 8744475 ↗