BD Insyte 381223Recalls & reported problems

Summary

The FDA's MAUDE database contains 73 adverse event reports that list this exact device (DI 00382903812233), received between Jan 24, 2018 and Mar 11, 2026 — classified as 7 injuries, 66 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (26 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 73 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 11, 2026Break

  IT WAS REPORTED THAT THE PATIENT HAD A CANNULATED VENOUS ACCESS SINCE THE PREVIOUS DAY; DURING THE ADMINISTRATION OF THERAPY, THE INFUSION PUMP ALARM WAS ACTIVATED AND, ON ASSESSING AND REMOVING THE DEVICE, A CATHETER FRACTURE WAS OBSERVED. IN ADDITION, SIGNS OF PHLEBITIS (ERYTHEMA AND LOCAL PAIN) WERE OBSERVED AT THE PUNCTURE SITE, WITH NO EVIDENCE OF FRAGMENT RETENTION OR OTHER IMMEDIATE COMPLICATIONS.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 24568794 ↗
• MalfunctionMar 10, 2026Break

  "DURING THE PERIPHERAL VENOUS CANNULATION PROCEDURE WITH INTRAVENOUS CATHETER, AT THE TIME OF INSERTION AND MANIPULATION OF THE DEVICE, A FRACTURE OF THE CATHETER BEVEL WAS EVIDENCED. THE PROCEDURE WAS IMMEDIATELY SUSPENDED, VERIFYING THE INTEGRITY OF THE DEVICE AND THE STATE OF THE PUNCTURE SITE. THE PATIENT WAS ASSESSED AND THERE WAS NO EVIDENCE OF IMMEDIATE COMPLICATIONS, SUCH AS ACTIVE BLEEDING, SEVERE PAIN OR SIGNS OF FRAGMENT RETENTION. SUBSEQUENTLY, THE DEVICE WAS DISCARDED ACCORDING TO INSTITUTIONAL PROTOCOL AND A NEW CANNULATION WAS PERFORMED WITH STERILE MATERIAL, WITH NO NEW DEVELOPMENTS. THE EVENT WAS REPORTED FOR FOLLOW-UP AND QUALITY CONTROL OF THE MEDICAL DEVICE. ADDITIONAL INFORMATION RECEIVED ON 26-FEB-2026 EMAIL FOLLOW UP: COULD YOU PLEASE CONFIRM HOW MANY UNITS OF THE PRODUCT PRESENTED THE ISSUE/DEFECT? IN RESPONSE TO YOUR COMMUNICATION REGARDING CLAIM NO. (B)(4), WE INFORM YOU THAT TWO (2) UNITS OF THE PRODUCT WITH THE REPORTED PROBLEM HAVE BEEN SUBMITTED. COULD YOU PROVIDE PHOTOS AND/OR VIDEOS OF THE PRODUCT SHOWING THE DEFECT? REGARDING THE EVIDENCE, IN THE FIRST CASE, THERE IS PHOTOGRAPHIC EVIDENCE, WHICH HAS ALREADY BEEN SENT FOR REVIEW. IN THE SECOND CASE,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24563587 ↗
• MalfunctionMar 10, 2026Break

  "DURING THE PERIPHERAL VENOUS CANNULATION PROCEDURE WITH INTRAVENOUS CATHETER, AT THE TIME OF INSERTION AND MANIPULATION OF THE DEVICE, A FRACTURE OF THE CATHETER BEVEL WAS EVIDENCED. THE PROCEDURE WAS IMMEDIATELY SUSPENDED, VERIFYING THE INTEGRITY OF THE DEVICE AND THE STATE OF THE PUNCTURE SITE. THE PATIENT WAS ASSESSED AND THERE WAS NO EVIDENCE OF IMMEDIATE COMPLICATIONS, SUCH AS ACTIVE BLEEDING, SEVERE PAIN OR SIGNS OF FRAGMENT RETENTION. SUBSEQUENTLY, THE DEVICE WAS DISCARDED ACCORDING TO INSTITUTIONAL PROTOCOL AND A NEW CANNULATION WAS PERFORMED WITH STERILE MATERIAL, WITH NO NEW DEVELOPMENTS. THE EVENT WAS REPORTED FOR FOLLOW-UP AND QUALITY CONTROL OF THE MEDICAL DEVICE. ADDITIONAL INFORMATION RECEIVED ON 26-FEB-2026. EMAIL FOLLOW UP: COULD YOU PLEASE CONFIRM HOW MANY UNITS OF THE PRODUCT PRESENTED THE ISSUE/DEFECT? IN RESPONSE TO YOUR COMMUNICATION REGARDING CLAIM NO. (B)(4), WE INFORM YOU THAT TWO (2) UNITS OF THE PRODUCT WITH THE REPORTED PROBLEM HAVE BEEN SUBMITTED. COULD YOU PROVIDE PHOTOS AND/OR VIDEOS OF THE PRODUCT SHOWING THE DEFECT? REGARDING THE EVIDENCE, IN THE FIRST CASE, THERE IS PHOTOGRAPHIC EVIDENCE, WHICH HAS ALREADY BEEN SENT FOR REVIEW. IN THE SECOND CASE,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24563582 ↗
• MalfunctionNov 10, 2025Nonstandard Device; Nonstandard Device

  MATERIAL # 381223 BATCH # 5067241 IT WAS REPORTED BY CUSTOMER THAT THE CATHETERS ARE BURRING WHEN TRYING TO PLACE IN PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23509752 ↗
• InjuryNov 5, 2025Break; Break

  INFLIXIMAB DOSE 1 IV INSERTED BY RN, TWO ATTEMPTS. ON COMPLETION OF INFUSION SOME PAIN AND BLEEDING AT SITE. AS PER PROTOCOL NEEDED TWO HOURS OBSERVATION, IV BLOOD WITHDREW AND FLUSHED, APPEARED PATENT, NO FURTHER PAIN. TWO HOURS LATER ON DISCHARGE ALL OBS STABLE, IV REMOVED. WHEN REMOVING CANNULA, IT APPEARED TO STILL BE INTACT, UPON PULLING THE CANNULA OUT A "SUCTION" SOUND WAS HEARD AND FELT, AND IT WAS OBSERVED THAT PART OF THE CANNULA TIP WAS MISSING.

  Patient problems: Foreign Body In Patient

  MAUDE report 23481724 ↗
• InjuryMay 21, 2025Adverse Event Without Identified Device or Use Problem; Air/Gas in Device; Adverse Event Without Identified Device or Use Problem; Air/Gas in Device

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pneumocephalus

  MAUDE report 22063391 ↗
• MalfunctionMay 5, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT BD INSYTE BL 22GA X 1.0IN CATHETER TIP INTEGRITY THE PATIENT WAS ADMITTED TO THE ICU BY THE EMERGENCY DEPARTMENT AT 23:35 ON (B)(6) 2025 DUE TO ¿HALF A DAY OF FATIGUE WITH THE INABILITY TO CALL OUT FOR MORE THAN 3 HOURS¿.THE PATIENT WAS DIAGNOSED WITH HYPERTENSIVE CEREBRAL HEMORRHAGE, REQUIRING REAL-TIME MONITORING OF BLOOD PRESSURE, AND INVASIVE BLOOD PRESSURE MONITORING WAS PLACED AT 00:05 ON (B)(6), GIVING THE USE OF THIS DISPOSABLE INTRAVENOUS INDWELLING NEEDLE PUNCTURE NEEDLE PLACEMENT. DURING THE PROCESS, THE HOSE SLEEVE WAS FOLDED AND THE TIP WAS EASILY SPLIT AND COULD NOT BE DELIVERED INTO THE BLOOD VESSEL SMOOTHLY. TRANSLATED WITH DEEPL.COM (FREE VERSION).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21961364 ↗
• MalfunctionNov 15, 2024Material Separation; Material Separation

  NONE REPORTED BD INSYTE BL 22GA X 1.0IN CATHETER BROKE SEPARATED. IT WAS REPORTED BY THE CUSTOMER THAT THE CLINIC REPORTS 1 OPENED BOX OF 50, INSTYE IV CATHETER, 22 G X 1.0¿, PART NUMBER: 381223, LOT 4025720, EXP. 1/29 ¿ STYLET CAME OFF OF THE VEIN OF THE PATIENT. THEY WERE ABLE TO REMOVE WITH NO ADVERSE EVENTS TO REPORT BUT DO NOT WANT TO KEEP REMAINING PRODUCT. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. THE CLINIC REPORTS 1 OPENED BOX OF 50, INSTYE IV CATHETER, 22 G X 1.0¿, PART NUMBER: 381223, LOT 4025720, EXP. 1/29 ¿ STYLET CAME OFF OF THE VEIN OF THE PATIENT. THEY WERE ABLE TO REMOVE WITH NO ADVERSE EVENTS TO REPORT BUT DO NOT WANT TO KEEP REMAINING PRODUCT. ADDITIONAL INFO: WE ARE WAITING ON AN UPDATE FROM THE CUSTOMER. AS THERE ARE NOW ADDITIONAL QUESTIONS BELOW, WE WILL FOLLOW UP FOR THE ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20699595 ↗
• MalfunctionNov 15, 2024Contamination; Contamination

  ON (B)(6) 2024, DURING A PAINLESS GASTROENTEROSCOPY PATIENT'S IV INDWELLING, A NEWLY REMOVED INDWELLING NEEDLE WAS FOUND TO HAVE A BLACK SPOT ON IT, WHICH WAS IMMEDIATELY REPLACED WITH ANOTHER INDWELLING NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20695893 ↗
• MalfunctionOct 17, 2024Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT BD INSYTE BL 22GA X 1.0IN DEFECTIVE NEEDLES IN CANNULA. WE HAVE SOME 22G BD INSYTE CANNULAS (REF 381223) HERE THAT HAVE BEEN REPORTED DEFECTIVE BY THE ANAESTHETISTS USING THEM, ALL FROM THE SAME BATCH (NO. 4101724). THE NEEDLE CATCHES ON THE INSIDE OF THE CANNULA IF YOU ATTEMPT TO REINSERT IT AND SOME HAVE VISIBLE KINKS ON THE OUTSIDE OF THE CANNULA. WE HAVE REMOVED THIS BATCH FROM OUR STOCK AND PUT ASIDE TO PREVENT FURTHER ISSUES. THE CANNULA NEEDLE APPEARED TO HAVE A COUPLE VERY SMALL BUMPS ON THE OUTSIDE. THE OTHERS HE SAID DIDN¿T GLIDE SMOOTHLY AND WOULD CATCH INTERNALLY; I BELIEVE HE HAD ISSUES WITH 3 TODAY. HIS CONCERN WAS PUSHING THROUGH THE PLASTIC AND LEAVING A PIECE OF PLASTIC IN THE PATIENT. THE CUSTOMER HAS PUT ASIDE THE REMAINING STOCK IN A BAG AND WILL RETURN ALL OF THE LEFTOVER STOCK. I DON'T HAVE AN EXACT NUMBER. NONE OF THE USED CANNULAS WERE KEPT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20476565 ↗
• MalfunctionJun 26, 2024Defective Component; Defective Component

  IT WAS REPORTED THAT BD INSYTE BL 22GA X 1.0IN CATHETER WAS DEFECTIVE / DAMAGED / DEFORMED WHEN USED IN THE CT ROOM, THE CATHETER INTERFACE END PROTRUDED AND THE DEFECTIVE QUANTITY CAN BE RETURNED AS 1 UNIT, CLAIMS NEED TO BE CLAIMED, COMPLAINT RESPONSE LETTER IS REQUIRED, COMPLAINT RECEIPT LETTER IS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19615010 ↗
• MalfunctionMay 24, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT BD INSYTE BL 22GA X 1.0IN CATHETER BROKE ONCE THEY PLACE THE CATHETER/CANNULA, WHEN THEY PULL THE STYLET PART OUT THE PLASTIC PART OF THE CANNULA HAS BROKEN OFF IN PIECES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19391345 ↗
• MalfunctionMay 6, 2024Leak/Splash; Leak/Splash

  CLINICIANS HAVE REPORTED A COUPLE OF INCIDENTS WITH THE 22G BD INSYTE WHERE THE PLASTIC AROUND THE BLUE HUB WHERE YOU WOULD PLACE THE IV SET IS FAULTY IT APPEARS THAT THE PLASTIC HAS BEEN DOUBLED MEANING YOU CAN ATTACH ANYTHING TO THE CANNULA WHEN IT HAS BEEN INSERTED INTO THE PATIENT. I HAVE ATTACHED PHOTOS TO SHOW YOU. IT APPEARS TO BE THE WHOLE LOT 3279818 THAT IS AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19256526 ↗
• MalfunctionMar 29, 2024Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT BD INSYTE BL 22GA X 1.0IN ADAPTER / CONNECTOR / HUB - NOT ABLE TO CONNECT TO MATING COMPONENT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS COMPLAINT CAME THROUGH TGA; PATIENT REQUIRES RE CANNULATION OR MULTIPLE CANNULATIONS. STOCK WITH BATCH NUMBER BATCH N#3237898. REMOVED FROM CIRCULATION. INTERNAL HOSPITAL S1 PRODUCT COMPLAINT FORM SUBMITTED. ADDITIONAL EVENT DESCRIPTION: ANAESTHETIST CANNULATED PATIENT SUCCESSFULLY. WHEN NEEDLE REMOVED AND BUNG ATTACHED THE BUND WAS NOT ABLE TO BE TIGHTENED (MULTIPLE BUNGS TRIED) THE CANNULA WAS REMOVED AND PATIENT REQUIRED RE CANULATION. CANULA DEEMED TO BE FAULTY. SEVERAL PATIENT'S SAME OUTCOME SEE ATTACHED - DIR 94964.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19006472 ↗
• MalfunctionMar 5, 2024Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT BD INSYTE BL 22GA X 1.0IN CONNECTOR / HUB - NOT ABLE TO CONNECT TO MATING COMPONENT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE BLUE CATHETER HUB DOES NOT ALLOW A CONNECTOR CAP TO BE SCREWED ON TO IT. REQUIRES PATIENT TO BE RE-CANNULATED. FOUND BY SEVERAL OF THE ANAESTHETIC TEAM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18839309 ↗
• MalfunctionDec 27, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD INSYTE YEL 22GA X 1IN LEAKED AT CATHETER JUNCTION THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AS DISCUSSED WITH ON THE PHONE, WE HAVE HAD 2 PROBLEMS WITH INSYTE CATHETERS OVER THE PAST 2 DAYS. THE FIRST WAS A 24GA 0.75IN THAT HAD A JAGGED EDGE ON THE TIP SO YOU COULD NOT USE OR PLACE THE CATHETER. I THOUGHT IT WAS A ONCE OFF SO THREW IT AWAY. I HAVE ATTACHED THE BATCH DETAILS ANYWAY. I HAVE NO IDEA IF OTHER CATHETERS IN THIS BATCH ARE AFFECTED AS WE RARELY USE THAT SIZE. THIS MORNING WE USED A 22GA 1 " INSYTE CATHETER WHICH WAS LEAKING BETWEEN THE SHEATH AND THE HUB. SEE PIC AND BATCH DETAILS. THESE CATHETERS WERE FROM OUR ORDER YESTERDAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18400448 ↗
• MalfunctionOct 13, 2023Crack; Crack

  FRAGILITY OF THE SHORT CATHETER. WHEN CHECKED BEFORE USE, THE TIP OF THE SHORT CATHETER CRACKED IN 2. USE OF AN INSYTE 20G ROSE 30MM SHORT CATHETER, REFERENCE (B)(4). WE HAVE 1 DEVICE AFFECTED + 12 OTHERS OF THE SAME REFERENCE AND BATCHES AFFECTED. THE DEVICE REMAINS AT YOUR DISPOSAL FOR EXPERT APPRAISAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17931183 ↗
• MalfunctionSep 19, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE NEEDLE WENT THROUGH 4 BOXES OF THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER. THE FOLLOWING WAS RECEIVED FROM THE INITIAL REPORTER: WE HAVE THE FOLLOWING PRODUCT THAT IS DEFECTIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17777032 ↗
• MalfunctionSep 18, 2023Material Deformation; Material Deformation

  IT WAS REPORTED WHILE USING BD INSYTE¿, PERIPHERAL IV CANNULA, BD VIALON¿ BIO MATERIAL THE CATHETER WAS DAMAGED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BEFORE USING THE INDENTATION NEEDLE, OPEN THE PACKAGE, CHECK THE NEEDLE CORE, FIND A WHITE RING ON THE UPPER END OF THE HOSE, SUSPECTED TO PRODUCE CREASES, REPLACE THE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17770239 ↗
• MalfunctionJul 19, 2023Defective Component; Defective Component

  IT WAS REPORTED THAT DURING USE WITH BD INSYTE¿ IV CATHETER 22GA X 1.00IN THE END CAP WAS UNABLE TO BE ATTACHED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: THE PATIENT UNDERWENT GASTROSCOPY. BEFORE OPERATION, HE WAS PREPARED TO PUNCTURE THE SUPERFICIAL VEIN WITH AN INDWELLING NEEDLE. IF THE PUNCTURE WAS SUCCESSFUL, HE WAS GIVEN A HEPARIN CAP TO SEAL THE TUBE MOUTH. THE HEPARIN CAP COULD NOT BE SCREWED ON. IF THE HEPARIN CAP WAS REPLACED, IT STILL COULD NOT BE SCREWED ON. MAKE RELEVANT EXPLANATIONS, AND CONDUCT SUPERFICIAL VEIN PUNCTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17348056 ↗
• MalfunctionJun 7, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE NEEDLE PIERCED THROUGH THE BD INSYTE¿ PERIPHERAL IV CANNULA WITH BD VIALON¿ BIOMATERIAL WHILE ATTEMPTING TO INSERT THE IV. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ON FRIDAY AFTERNOON, (B)(6) 2023, ONE OF OUR DOCTORS ATTEMPTED TO USE THE... CANNULA TO INSERT AN IV LINE INTO A PATIENT¿S L) CUBITAL FOSSA. AS HE TRIED TO PUSH THE TROCHAR THROUGH THE SKIN THE TIP OF THE CANNULA LIFTED... PREVENTING THE CANNULA FROM ENTERING THE VEIN THOUGH THE TROCHAR TIP HAD PENETRATED IT. NO DAMAGE WAS DONE TO THE PATIENT AS IT WAS NOTICED AND WITHDRAWN IMMEDIATELY. SUBSEQUENT CANNULATION WITH A CANNULA FROM THE SAME BATCH CAUSED NO ISSUES. THE CANNULA HAD BEEN STORED AT ROOM TEMPERATURE AS DO ALL OUR OTHERS AND WAS OPENED JUST PRIOR TO USE. IT WAS NOT PLACED ON ANY SURFACE AFTER THE CAP HAD BEEN REMOVED SO WE COULD NOT HAVE ACCIDENTALLY DAMAGED IT. THIS IS THE FIRST TIME THAT EITHER THE DOCTOR OR MYSELF HAD COME ACROSS THIS ISSUE"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17076560 ↗
• MalfunctionMay 25, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE BD INSYTE¿ PERIPHERAL IV CANNULA WITH BD VIALON¿ BIOMATERIAL NEEDLE PIERCED THROUGH AND BECAME STUCK IN THE CAP BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "OUT OF BOX FAILURE - TECH OPENED NEW CATHETER AND FOUND NEEDLE STUCK IN PLASTIC CAP"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17007836 ↗
• MalfunctionMay 11, 2023Break; Break

  IT WAS REPORTED THAT THE BD INSYTE¿ IV CATHETER WAS BROKEN AT THE TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS FEEDBACK FROM OPERATING ROOM OF ANESTHESIA DEPARTMENT. NURSES COMPLAINED THAT THE NEEDLE IS BLUNT WHEN INSERTING IV CATHETER. WHEN FAILING IN INSERTING CATHETER, NURSE WITHDREW CATHETER AND SAW THAT THE CATHETER WAS BROKEN AT THE TIP. CATHETER BROKEN AT THE TIP: NURSES CONCERN MAY HAPPEN THE SITUATION THAT DROP IN THE VEIN OF PATIENT AND STUCK SOMEWHERE IN CIRCULATORY SYSTEM (CURRENTLY DIDN'T HAPPEN THIS SITUATION WITH BD CATHETER BUT HAPPENED WITH OTHER CATHETER FROM COMPETITOR (INDIA BRAND) SO WHEN THE CATHETER BROKEN AT THE TIP, NURSE HAVE SUCH CONCERN) NEEDLE IS BLUNT: NURSES COMPLAINT THAT DIFFICULT TO INSERT IV CANNULA IN THE VEIN, CREATE PAIN TO PATIENT AND NURSE CAN'T USE THAT CATHETER ANYMORE, WASTE HOSPITAL'S BUDGET.

  Patient problems: Pain

  MAUDE report 16916199 ↗
• MalfunctionMay 1, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED WHILE USING BD INSYTE¿, PERIPHERAL IV CANNULA, BD VIALON¿ BIO MATERIAL THE NEEDLE PIERCED THE CATHETER. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (B)(4) ¿ THE CATHETER IS PEELING AWAY FROM THE NEEDLE EVERY TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16842399 ↗
• MalfunctionApr 21, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD INSYTE¿ PERIPHERAL IV CANNULAS WITH BD VIALON¿ BIOMATERIAL LEAKED DURING USE CAUTIOUSLY REPORTED AS SERIOUS INJURY. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED REPORTABLE INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. TRANSLATED FROM FRENCH: "THE DIFFERENT DEPARTMENTS REPORTED A VENITIS, DIFFUSION OR LEAKAGE PROBLEM THE DAY AFTER THE CATHETER WAS POSTED 3 DIFFERENT CATHETERS INVOLVED. PATIENT CARE: CATHETER DIFFUSED OVER HAND, INDURATION, VENITIS.

  Patient problems: Vasculitis

  MAUDE report 16792217 ↗