INTROCAN SAFETY® 4251601-020Recalls & reported problems
B. Braun Medical Inc. · INTROCAN SAFETY PUR 24G, 0.7X19MM-US · Class 2
All models of INTROCAN SAFETY (46)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This B. Braun Introcan Safety intravenous cannula is a short-term plastic catheter placed into a vein. Reports mostly describe the cannula breaking or coming apart, sometimes leaving a piece inside the patient, along with leaking at the hub connection and needlestick injuries despite the safety mechanism. There are 32 reports, with 21 injuries and no deaths. 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
- 32
- Deaths reported
- 0
- Injuries reported
- 21
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 04046964478673), received between Sep 4, 2018 and Sep 5, 2023 — classified as 21 injuries, 11 malfunctions.
The most frequently reported specific device problem is “Break” (11 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
Device problems
- Break11
- Fluid/Blood Leak10
- Detachment of Device or Device Component6
- Fracture3
- Fail-Safe Problem2
- Air/Gas in Device1
- Protective Measures Problem1
Patient problems
- Foreign Body In Patient13
- No Clinical Signs, Symptoms or Conditions10
- Device Embedded In Tissue or Plaque4
- Needle Stick/Puncture3
- Discomfort1
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 5, 2023Break; Break
AS REPORTED BY THE USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN BELGIUM: "PUR WAS BROKEN OFF" ACCORDING TO THE CUSTOMER: "THE CUSTOMER REMOVED THE CATHETER FROM THE HAND BACK A PATIENT AND FOUND THAT A PIECE WAS MISSING AT THE TIP OF THE "TUBE" (PUR WAS BROKEN OFF ON APPROXIMATELY +/- 1CM - SEE ATTACHED PICTURE). THE MISSING PART IS PROBABLY STILL INSIDE THE PATIENT. AN ULTRASOUND WAS PERFORMED IMMEDIATELY BUT NOTHING COULD BE SEEN."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17685141 ↗InjuryAug 29, 2023Break; Break
AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN SWEDEN; "NEEDLE BROKEN OFF." "ANESTHESIOLOGIST IS TO APPLY SPINAL ANESTHESIA TO A WOMAN IN LABOR. DURING THE PROCEDURE, A PINK IS USED RETRACTOR CANNULA TO PIERCE THE SKIN, THE SPINAL NEEDLE IS THEN INSERTED THROUGH THE PINK CANNULA (THE PINK THE CANNULA IS USED AS AN INTRODUCER). WHEN REVERSING THE SPINAL NEEDLE, IT IS PERCEIVED AS BEING STUCK. IT COMES OFF BUT WHEN IT COMES OUT OF THE PATIENT, ABOUT 6 CM OF THE DISTAL PART OF THE SPINAL NEEDLE IS MISSING. AFTER CONSULTATION WITH A SPINAL SURGEON, NO IMMEDIATE ACTION WAS TAKEN AND THE PATIENT WAS DELIVERED. AFTER DELIVERY, A PLAIN X-RAY WAS TAKEN. THE NEEDLE WAS SUPERFICIAL. THE SPINE SURGEON WAS ABLE TO REMOVE THE NEEDLE UNDER LOCAL ANAESTHETIC. WE HAVE TRIED TO REPLICATE THE RESULTS WITH INTERRUPTED SPINAL NEEDLE BY SIMULATING THE COURSE WITH A PINK RETRACTOR CANNULA AND A SPINAL NEEDLE WITHDRAWN THROUGH THE CANNULA. THIS HAS NOT, DESPITE REPEATED ATTEMPTS RESULTED IN A SPINAL NEEDLE OF THE SAME MAKE BREAKING OFF. HOWEVER, IT CANNOT BE RULED OUT THAT THE FAULTY ACTIVE USE WAS THE CAUSE OF THE INCIDENT."
Patient problems: Foreign Body In Patient
MAUDE report 17646474 ↗InjuryJul 5, 2023Break; Break
AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN NETHERLANDS: "IVC CATHETER BROKEN? (SHORTER NORMAL)". ACCORDING TO THE CUSTOMER: "REASON OF COMPLAINT: BY REMOVING THE IVC CATHETER, THE NURSE FOUND OUT THAT THE IVC CATHETER SHORTER WAS THAN NORMAL. MAYBE THERE IS A PIECE FROM THE CATHETER LEFT BEHIND IN THE PATIENT. THE DOCTOR EXAMINED THE PATIENT BUT COULD NOT FOUND ANYTHING".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17262045 ↗InjuryJul 5, 2023Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY (B)(6)ORGANIZATION IN FRANCE: "CATHETER-LEAKAGE." ACCORDING TO THE CUSTOMER: "CATHETER LEAKAGE AT THE JUNCTION BETWEEN THE HUB AND THE CANNULA. THE LEAK WAS DETECTED DURING ADMINISTRATION."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17261209 ↗InjuryJul 5, 2023Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN CHINA: "BLOOD LEAKAGE." ACCORDING TO THE CUSTOMER: "THE NURSE HAD NOT YET EXTRACTED THE NEEDLE CORE DURING THE PUNCTURE. THE BACK OF THE NEEDLE HOLDER KEEPS EMITTING BLOOD. THE NURSE DENIED REPEATED PUNCTURES AND DENIED LOOSENING THE NEEDLE CORE TO PUNCTURE THE CATHETER. THE VIDEO SHOWS THAT THERE IS A LEAKAGE AT THE END OF THE CATHETER AND THE NEEDLE SEAT. CAUSES A LARGE AMOUNT OF BLOOD TO OVERFLOW."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17260999 ↗InjuryJun 22, 2023Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component
AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN UNITED KINGDOM: "PLASTIC CANNULA CAME APART." "I AM JUST WRITING REGARDS A SITUATION THAT HAPPENED THIS WEEK INVOLVING A PATIENT - A PATIENT HAD A 22G CANNULA (IS3) WHICH DEVELOPED A LEAK, JUST WHERE THE CANNULA TUBING JOINED THE CANNULA HUB, THEN THE SAME PATIENT HAD A 20G (IS3) CANNULA WHICH CAME APART, THE LENGTH OF THE CANNULA TUBING WAS NOT ATTACHED TO THE HUB WHEN THE DRESSING WAS TAKEN DOWN, AND THE CANNULA TUBING IS STILL IN THE ARM. OBVIOUSLY, THEY WERE BOTH DIFFERENT GAUGE CANNULAS, SO DIFFERENT LOT NUMBERS. UNFORTUNATELY, THE CANNULAS WEREN'T KEPT FOR FURTHER INVESTIGATION."
Patient problems: Discomfort
MAUDE report 17182817 ↗InjuryJun 14, 2023Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN CHINA: "BLOOD LEAKAGE." "THERE WAS BLOOD LEAKAGE AT THE CONNECTION BETWEEN THE HUB AND THE CATHETER."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17124924 ↗InjuryJun 7, 2023Fail-Safe Problem; Fail-Safe Problem
AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN TAIWAN: "NEEDLE STICK INJURIES." "SAFETY DEVICE ACTIVATED BUT NURSE STILL INJURED BY THE NEEDLE."
Patient problems: Needle Stick/Puncture
MAUDE report 17078385 ↗InjuryJun 7, 2023Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component
AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN UNITED KINGDOM: "IV WAS FOUND TO BE LEAKING. ON INVESTIGATION CATHETER HAD BECOME UNATTACHED FROM DEVISE AND STAYED IN PATIENT REQUIRING CT AND REMOVAL. THE OUTCOME OF THIS IS THAT THE RETAINED FRAGMENT OF THE CATHETER WAS SURGICALLY REMOVED AND THERE WAS NO FURTHER HARM TO THE PATIENT.".
Patient problems: Foreign Body In Patient
MAUDE report 17078384 ↗InjuryFeb 5, 2023Break; Break
AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN BRASIL: "BROKEN/ PRODUCT." "YESTERDAY, (B)(6) 2023, WE HAD A SITUATION WITH A PATIENT WHO WAS USING THE INTROCAN SAFETY. WHEN THE NURSING TECHNICIAN CHANGED THE PATIENT'S DRESSING, SHE CHECKED THAT THE CATHETER BROKE INSIDE HER ARM. ONLY THE EXTERNAL PART CAME OUT AND THE NEEDLE REMAINED INSIDE THE VEIN. THE PATIENT WAS REFERRED TO SURGICAL PROCEDURE TO REMOVE THE ITEM."
Patient problems: Foreign Body In Patient
MAUDE report 16302035 ↗InjuryDec 29, 2022Break; Break
AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN SWEDEN; "NEEDLE BROKEN OFF." "ANESTHESIOLOGIST IS TO APPLY SPINAL ANESTHESIA TO A WOMAN IN LABOR. DURING THE PROCEDURE, A PINK IS USED RETRACTOR CANNULA TO PIERCE THE SKIN, THE SPINAL NEEDLE IS THEN INSERTED THROUGH THE PINK CANNULA (THE PINK THE CANNULA IS USED AS AN INTRODUCER). WHEN REVERSING THE SPINAL NEEDLE, IT IS PERCEIVED AS BEING STUCK. IT COMES OFF BUT WHEN IT COMES OUT OF THE PATIENT, ABOUT 6 CM OF THE DISTAL PART OF THE SPINAL NEEDLE IS MISSING. AFTER CONSULTATION WITH A SPINAL SURGEON, NO IMMEDIATE ACTION WAS TAKEN AND THE PATIENT WAS DELIVERED. AFTER DELIVERY, A PLAIN X-RAY WAS TAKEN. THE NEEDLE WAS SUPERFICIAL. THE SPINE SURGEON WAS ABLE TO REMOVE THE NEEDLE UNDER LOCAL ANAESTHETIC. WE HAVE TRIED TO REPLICATE THE RESULTS WITH INTERRUPTED SPINAL NEEDLE BY SIMULATING THE COURSE WITH A PINK RETRACTOR CANNULA AND A SPINAL NEEDLE WITHDRAWN THROUGH THE CANNULA. THIS HAS NOT, DESPITE REPEATED ATTEMPTS RESULTED IN A SPINAL NEEDLE OF THE SAME MAKE BREAKING OFF. HOWEVER, IT CANNOT BE RULED OUT THAT THE FAULTY ACTIVE USE WAS THE CAUSE OF THE INCIDENT."
Patient problems: Foreign Body In Patient
MAUDE report 16075695 ↗InjuryDec 20, 2022Break; Break
AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN COLOMBIA: "BROKEN DEVICE." "PATIENT WHO CONSULTED A HEALTH INSTITUTION FOR ABDOMINAL PAIN ON (B)(6) 2022, WHO WAS GIVEN AN INTRAVENOUS CATHETER FOR MEDICATION. THE CATHETER IS REMOVED FROM THE PATIENT FOR DISCHARGE. PATIENT RE-CONSULTS FOR PAIN AT THE CATHETER INSERTION SITE AND POOR MOBILITY. THE PATIENT REPORTED "I FEEL LIKE I'M SQUEEZING". WITH ULTRASOUND THE ATTENDING PHYSICIAN IDENTIFIES INTRAMUSCULAR FOREIGN BODY WITH THROMBOSIS AND REQUIRES REFERRAL TO A VASCULAR PHYSICIAN FOR FOREIGN BODY REMOVAL."
Patient problems: Foreign Body In Patient
MAUDE report 16018952 ↗InjuryNov 23, 2022Break; Break
AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN CHINA: "TUBE BROKEN." ACCORDING TO THE CUSTOMER: "THE PATIENT WAS IN NORMAL CONDITION DURING USE. WHEN THE NURSE PULLED OUT THE NEEDLE AFTER THE INFUSION TREATMENT, FOUND THAT PART OF TUBE WAS IN THE PATIENT'S BODY. THE DEPARTMENT COOPERATED WITH THE VASCULAR SURGERY CONSULTATION TO REMOVE THE REMAINING TUBE FROM THE PATIENT'S BLOOD VESSELS."
Patient problems: Foreign Body In Patient
MAUDE report 15859449 ↗InjuryOct 27, 2022Break; Break
AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN AUSTRALIA: "TIP OF CATHETER REMAINED IN VEIN." "WE HAVE HAD AN INCIDENT INVOLVING ONE OF THE BBRAUN CANNULAS WE USE (24G INTROCAN SAFETY CANNULA). ON REMOVAL OF THE CANNULA POST UNSUCCESSFUL CANNULATION IT WAS NOTED THAT PART OF THE TIP OF THE CANNULA WAS MISSING. THE PATIENT WAS SENT FOR ULTRASOUND GIVEN THE THROMBUS RISK IF SOME OF THE CANNULA HAD BROKEN OFF AND ON ULTRASOUND IT WAS IDENTIFIED THAT THE TIP OF THE CANNULA REMAINED IN THE VEIN. THE PATIENT HAD TO HAVE VASCULAR REVIEW AND SURGERY WHICH WAS PERFORMED OVER THE WEEKEND TO REMOVE THE CANNULA PIECE FROM HER VEIN. CUSTOMER DOES NOT KNOW THE LOT NUMBER BUT THERE ARE TWO BATCHES AVAILABLE: 22C24G8315 AND 22C22G8316."
Patient problems: Foreign Body In Patient
MAUDE report 15681845 ↗InjurySep 16, 2022Break; Break
AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN AUSTRALIA: "CATHETER BROKEN." "THE REGISTERED NURSE (RN) CARING FOR PATIENT WAS FLUSHING THE PIVC WITH NORMAL SALINE SITUATED ON HER R) CUBITAL FOSSA. WHILST FLUSHING THE PIVC IT WAS NOTED BY THE RN THE DRESSING WAS WET AND LEAKING FROM THE PIVC INSERTION SITE. THE RN HAD STOPPED FLUSHING THE PIVC AND DECIDED TO REMOVE THE DRESSING TO SEE WHY THE PIVC WAS LEAKING. WHEN THE DRESSING WAS REMOVED IT WAS OBSERVED THAT THE 16G PIVC HUB/BUNG PART WAS WITHOUT THE WHITE PLASTIC LUMEN. THE RN LOOKED THROUGH DRESSING TO SEE IF IT WAS STUCK TO THE DRESSING AND THEN PALPATED THE CANNULA SITE WHERE SHE COULD FEEL THE WHITE PLASTIC LUMEN STILL IN THE VEIN. THE RN REQUESTED ANOTHER NURSE TO RE-EXAMINE AND THIS WAS REPORTED THE TREATING TEAM (TT) RMO WHO EXAMINED THE SITE. THE TT RMO ADVISED FOR THE DRESSING TO BE REMOVED ALONG WITH THE DETACHED HUB AND APPLY DOTS TO THE SITE FOR THE SURGICAL REGISTRAR TO EXAMINE AND ULTRASOUND. PATIENT WAS BOOKED IN FOR EXPLORATION AND REMOVAL OF FOREIGN BODY."
Patient problems: Foreign Body In Patient
MAUDE report 15442260 ↗InjurySep 1, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN SOUTH AFRICA): "PIECE OF INTROCAN LEFT IN PATIENTS FOOT". ACCORDING TO THR CUSTOMER: "PATIENT HAD INTROCAN 24G INSERTED ON THE RIGHT FOOT DUE TO DIFFICULT VEINS. (B)(6) 2022 - EVENING - LINE OUT. (B)(6) 2022 - THEY DISCOVERED THAT A PIECE OF INTROCAN WAS STILL IN THE VEIN OF THE PATIENTS FOOT. (B)(6) 2022 - PATIENT WAS TAKEN TO THEATRE AND THE PIECE OF INTROCAN REMOVED FROM THE VEIN IN THE FOOT."
Patient problems: Foreign Body In Patient
MAUDE report 15341177 ↗MalfunctionAug 18, 2022Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN GERMANY: "STAMP OF SYRINGE IS LEAKY." "LEAKAGE OF HEPARIN SYRINGE, STAMP (RUBBER) LEAKING. 48 MIN AFTER START OF TREATMENT. NO DEVICE ALARM.. PERSONAL INJURY: APPROX. 400 ML BLOOD LOSS."
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 15249770 ↗InjuryJul 8, 2022Break; Break
AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN GERMANY: "CANNULA IS BROKEN OFF." "THE CANNULA BROKE IN THE SPINAL CANAL DURING THE BIRTH PREPARATION "SECTIO". AND HAD TO BE SURGICALLY REMOVED BY A NEUROSURGEON, AFTER THE BIRTH OF THE CHILD."
Patient problems: Foreign Body In Patient
MAUDE report 14960137 ↗MalfunctionJul 8, 2022Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN JAPAN). "PRODUCT LEAKAGE." "DURING INFUSION, LEAKAGE FROM THE CONNECTION PART WAS CONFIRMED. NO INFECTION / NO HEALTH HAZARD TO PATIENT / SAMPLE AVAILABLE / PROBABLE BATCH: 21L07G8374/21G18G8372."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14958171 ↗MalfunctionJul 1, 2022Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN JAPAN. "PRODUCT LEAKAGE." "LEAKAGE OCCURRED FROM THE CONNECTION WHEN THE USER TRIED TO FLASH. IT COULD ONLY PULL AIR WHEN PULLED WITH A SYRINGE. THE PATIENT HAS NO INFECTION / HEALTH HAZARD TO PATIENT: NONE / BATCH: 21L07G8374. SAMPLE: AVAILABLE, IT WILL BE SHIPPED LATER. "
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14888059 ↗MalfunctionJul 1, 2022Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN JAPAN "LEAKAGE WAS CONFIRMED." "DURING INFUSION, LEAKAGE FROM THE CONNECTION PART WAS CONFIRMED. PROBABLE BATCH: 20N04G8371/20A18G8371/20F29G8371. THE USED ACTUAL SAMPLE IS NOT AVAILABLE. UNUSED SAMPLES FROM 3 PROBABLE BATCHES (TOTAL 61 PIECES) ARE AVAILABLE: 20N04G8371: 50PIECES 20A18G8371: 8 PIECES 20F29G8371: 3 PIECES."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14887967 ↗MalfunctionJun 2, 2022Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN (B)(6) "PRODUCT LEAKAGE." "DURING ADMINISTRATION OF THE ANTICANCER DRUG IN THE CHEMOTHERAPY ROOM, LIQUID LEAKAGE FROM THE INFUSION SET CONNECTION WAS CONFIRMED. WE WILL ALSO COLLECT AND SEND ALL UNUSED ITEMS OF THE SAME LOT AS THE TWO ACTUAL ITEMS. THE PATIENT HAS NO INFECTION / HEALTH HAZARD TO PATIENT: NONE / SAMPLE: AVAILABLE / BATCH: 21L07G8374."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14577796 ↗InjuryJun 2, 2022Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN (B)(6). "AIR CAME IN FROM THE CONNECTION." "THERE WAS A REPORT THAT AIR WAS MIXED IN FROM THE INFUSION CONNECTION PART. IT OCCURRED IN AN OUTPATIENT AND EMERGENCY DEPARTMENT AT (B)(6) HOSPITAL. IT OCCURRED IN 7 CONSECUTIVE CASES AFTER SWITCHING TO THIS LOT: 21G04G8373. WE WILL COLLECT AND SHIP ALL THE SAME LOT UNUSED PRODUCTS IN THE HOSPITAL INVENTORY. THE PATIENT HAS NO INFECTION / HEALTH HAZARD TO PATIENT: NONE . SAMPLE: AVAILABLE / BATCH: 21G04G8373 ."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14577448 ↗InjuryMar 9, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED BY THE USER FACILITY ((B)(4)): "CANNULA LEFT IN PATIENTS VEIN". "THE CANNULA FELL OUT WHEN STAFF TRIED TO RE-INSERT IT AND THE PATIENT REPORTED THAT THE INSERTION SITE WAS PAINFUL. WHEN STAFF EXAMINED THE CANNULA THAT FELL OUT, THEY FOUND IT WAS SHORTER THAN NORMAL. PART OF THE CANNULA WAS STILL IN THE PATIENT'S VEIN."
Patient problems: Foreign Body In Patient
MAUDE report 13711262 ↗InjuryFeb 26, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN (B)(6). "PLASTIC PART OF CANULLA STAY IN THE BODY." ACCORDING TO THR CUSTOMER: "DURING EXTRACTION OF THE CANNULA TEMPOROPARIETALLY ON THE LEFT, AN INCOMPLETE PLASTIC FLEXIBLE PART OF THE CANNULA WAS PULLED OUT - ABOUT 2CM BROKE OFF, REMAINING IN THE VEIN. SURGICAL EXTRACTION WAS PERFORMED WITHOUT DIFFICULTY UNDER STERILE CONDITIONS, STERILSTRIP FIXATION, STERILE COVER."
Patient problems: Foreign Body In Patient
MAUDE report 13608332 ↗
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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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