BD Cathena Safety IV Catheter 386811Recalls & reported problems
Becton, Dickinson And Company · CATHENA 20GX1.25IN WINGED BC · Class 2
All models of BD Cathena Safety IV Catheter (33)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This BD Cathena safety IV catheter is a short-term winged IV catheter with a retractable needle. The 32 reports mostly describe the safety shield failing to activate when the needle is withdrawn, leaving the needle tip exposed, plus leaking, bits of loose plastic at the catheter tip, and contamination. Four reports describe 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
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00382903868117), received between Apr 2, 2019 and Jan 27, 2026 — classified as 4 injuries, 28 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (12 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.
Reports received per month
Most reported problems
Device problems
- Leak/Splash12
- Retraction Problem5
- Material Protrusion/Extrusion4
- Activation Failure2
- Activation Problem2
- Break2
- Defective Component2
- Device Contamination with Chemical or Other Material2
Patient problems
- No Clinical Signs, Symptoms or Conditions17
- No Consequences Or Impact To Patient6
- Exposure to Body Fluids2
- No Known Impact Or Consequence To Patient2
- Extravasation1
- Foreign Body In Patient1
- Insufficient Information1
- Needle Stick/Puncture1
Recent adverse event reports
The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 27, 2026Activation Problem
IT WAS REPORTED THAT BD CATHENA 20GX1.25IN WINGED BC SAFETY SHIELD ACTIVATION FAILED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24189508 ↗MalfunctionJan 6, 2026Retraction Problem
IT WAS REPORTED THAT BD CATHENA 20GX1.25IN WINGED BC NEEDLE RETRACTION FAILURE DATE OF THE INCIDENT: (B)(6) 2025 IT WAS REPORTED THAT, FAILURE TO ACTIVATE THE SAFETY SYSTEM ON THE CATHETER PUNCTURE CANULA. THE DEVICE HAS BEEN KEPT AT THE PHARMACY AND IS AVAILABLE FOR EXAMINATION IF YOU WISH: YOU CAN SEND A COURIER TO THE FOLLOWING ADDRESS: (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23978395 ↗MalfunctionDec 18, 2025Activation Failure; Activation Failure
IT WAS REPORTED THAT BD CATHENA 20GX1.25IN WINGED BC SAFETY SHIELD ACTIVATION FAILED. IT WAS REPORTED THAT IT APPEARS TO HAVE ENCOUNTERED SAFETY PROBLEMS. THIS IS THE SECOND TIME IN AS MANY WEEKS THAT THE SECURE INTRAVENOUS CATHETER HAS FAILED TO SECURE ITSELF WHEN THE CANULA IS WITHDRAWN, WITH THE DEVICE COVERING THE SPIKE REMAINING STUCK AT THE BASE. WHEN DID THE INCIDENT OCCUR? DURING USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23839222 ↗MalfunctionDec 18, 2025Activation Failure; Activation Failure
IT WAS REPORTED THAT BD CATHENA 20GX1.25IN WINGED BC SAFETY SHIELD ACTIVATION FAILED. IT WAS REPORTED THAT IT APPEARS TO HAVE ENCOUNTERED SAFETY PROBLEMS. THIS IS THE SECOND TIME IN AS MANY WEEKS THAT THE SECURE INTRAVENOUS CATHETER HAS FAILED TO SECURE ITSELF WHEN THE CANULA IS WITHDRAWN, WITH THE DEVICE COVERING THE SPIKE REMAINING STUCK AT THE BASE. WHEN DID THE INCIDENT OCCUR? - DURING USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23839221 ↗MalfunctionJun 5, 2025Activation Problem; Activation Problem
IT WAS REPORTED THAT BD CATHENA 20GX1.25IN WINGED BC SAFETY SHIELD ACTIVATION FAILED SAFETY MECHANISM: THE CANULA WAS NOT PROTECTED WHEN THE CATHETER WAS REMOVED THE CANULA WAS NOT ENCAPSULATED AFTER REMOVAL OF THE CATHETER - SEE PHOTOS WHEN DID THE INCIDENT OCCUR? - DURING USE WE'VE HAD A FEW PROBLEMS WITH CATHETERS AT THE CLINIC, PARTICULARLY IN THE OPERATING THEATRE. ACCORDING TO THE NURSES, THE CATHETERS SOMETIMES DON'T GO INTO ¿PROTECTION MODE¿ AND ARE VERY DIFFICULT TO PLACE. THE OPERATING THEATRE NURSE SENT ME THE ATTACHED PHOTOS FOR REFERENCE AND BATCH INFORMATION. HAVE YOU HAD ANY OTHER COMPLAINTS ABOUT THIS BATCH? AFTER RE-DISCUSSION WITH THE OPERATING ROOM TEAM, THEY HAVE DECIDED FOR THE MOMENT TO KEEP THIS LOT (BECAUSE THIS LOT IS THE MAJORITY IN OUR STOCK). AS THIS ONLY CONCERNED A FEW ISOLATED CASES AND THE EQUIPMENT THAT SEEMED DEFECTIVE WAS NOT KEPT, THE OPERATING ROOM CONTINUES WITH THESE CATHETERS AND THE HEAD NURSE OF THE DEPARTMENT WILL RESENSITIZE HER STAFF TO KEEP THE EQUIPMENT IF A FUTURE INCIDENT OCCURS. I WILL OF COURSE KEEP YOU INFORMED IF WE HAVE ANY NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22150888 ↗MalfunctionMay 27, 2025Contamination /Decontamination Problem; Material Integrity Problem; Contamination /Decontamination Problem; Material Integrity Problem
IT WAS REPORTED THAT THE BD CATHENA 20GX1.25IN WINGED BC HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PLEASE NOTE CUSTOMER IS STILL EXPERIENCING ISSUES (SINCE MARCH) WITH CATHENA AND WAS ALREADY ESCALATED THAT IT HAS A REAL RISK FOR PATIENT SAFETY IF THIS PLASTIC IS EMBOLIZED THROUGH THE VEINS. ONCE AGAIN, WE ARE FACING ANOTHER INCIDENT WITH YOUR SHORT CATHETERS REFERENCE 386811, AND WE STILL HAVEN'T RECEIVED AN ANSWER TO THE CAUSE OF THE FIRST INCIDENTS DETECTED WITH THESE CATHETERS ON THE 25TH OF MARCH. AS I TOLD YOU IN AN EMAIL ON 15 APRIL: THE INCIDENTS DETECTED TODAY IN THE (B)(6) HOSPITAL IN DIFFERENT BATCHES OF THIS REFERENCE, SEEM TO US TO BE IMPORTANT AND SERIOUS FOR PATIENT SAFETY (ATTACHED PHOTOS), AND THE INSECURITY THAT BECTON IS CAUSING AMONG OUR PROFESSIONALS REGARDING THE USE OF THESE CATHETERS IS VERY HIGH. WE HAVE NOT RECEIVED ANY HEALTH ALERT ABOUT YOUR PRODUCTS, AND IN VIEW OF THE INCIDENTS DETECTED, I UNDERSTAND THAT IT SHOULD BE YOUR RESPONSIBILITY TO REPORT THEM TO THE AEMPS, AS WE INDICATED TO YOU IN MARCH. 14-MAY-2025: FROM AEMPS MAIL: THE VIGILANCE AREA OF MEDICAL DEVICES OF THE SPANISH AGENCY OF MEDICINES AND MEDICAL
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22092130 ↗MalfunctionMar 26, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT BD CATHENA 20GX1.25IN WINGED BC CATHETER TIP INTEGRITY WE ARE TOLD THAT THE TIP OF THE CATHETER HAS A SMALL PIECE OF PLASTIC THAT MOVES, AS IF IT WERE LOOSE.BEFORE USE WE ARE TOLD THAT THE TIP OF THE CATHETER HAS A SMALL PIECE OF PLASTIC THAT MOVES, AS IF IT WERE LOOSE. THIS INCIDENCE IS CONSIDERED A HIGH RISK FOR PATIENT SAFETY. THE AFFECTED PRODUCT IS IN THE OPERATING ROOM OF (B)(6). NO COMMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21698686 ↗MalfunctionJan 8, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21103689 ↗MalfunctionDec 6, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
PLEASE FIND ENCLOSED AN ADVERSE EVENT REPORT CONCERNING THE FOLLOWING DM: CATHETER BD CATENARY 20G. REF 386811. LOT 2238458. IT HAS BEEN RETAINED AND IS AVAILABLE FOR COLLECTION AND ANALYSIS. WHEN OPENING THE CATHETER TO INFUSE THE PATIENT AND CHECKING THE EQUIPMENT BEFORE PRICKING, A SMALL PIECE OF PLASTIC PIECE OF PLASTIC ¿HANGING¿ FROM THE PLASTIC CANNULA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20869844 ↗MalfunctionJun 21, 2024Break; Break
MULTIGUARD DEFECT ¿ONCE THE CATHETER HAS BEEN INSERTED INTO THE VEIN. PLASTIC PART OF THE NON-RETURN VALVE REMOVED WHEN THE CANULA WAS REMOVED. CATHETER UNUSABLE WITH VALVE CLOSED¿. THE DEFECTIVE MEDICAL DEVICE HAS BEEN RETURNED TO THE PHARMACY, AND IS AVAILABLE FOR RETURN TO THE LABORATORY BY COURIER. HOW DO YOU WISH TO PROCEED WITH THE RETURN TO THE LABORATORY? WHEN DID THE INCIDENT OCCUR? UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 19589249 ↗InjuryOct 31, 2023Leak/Splash; Migration or Expulsion of Device; Defective Component; Leak/Splash; Migration or Expulsion of Device; Defective Component
PIVC GO OUT THE VEIN AFTER CONTRAST INJECTION (SCANNER) - PERMEABILITY IS OK BEFORE THE EXAM. AFTER USE: CONSEQUENCES: EXTRAVASATION OF CONTRAST MEDIUM. IN SOME CASES, RADIOLOGY HAS BEEN PERFORMED TO VISUALIZE THE EXTRAVASATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18041795 ↗MalfunctionApr 18, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE BD CATHENA¿ SAFETY IV CATHETER WITH WINGS AND BD MULTIGUARD¿ TECHNOLOGY LEAKED CONTRAST MEDIA DURING THE HIGH-PRESSURE INJECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: "DURING INJECTIONS OF CONTRAST PRODUCTS (VISCOUS AND THICK) AT A FLOW RATE OF 4-5CC/S, THE OVERPRESSURE CREATED LEADS TO A LEAKAGE OF THE CONTRAST PRODUCT AND THE IMPOSSIBILITY OF MAKING IMAGES AT AN "ARTERIAL" TIME. CONSEQUENCES: LEAKAGE OF STICKY CONTRAST MEDIUM ON OUR FRAGILE MACHINES. FAILED EXAMINATIONS WITH DILUTED CONTRAST PRODUCTS ON A PATIENT WITH MODERATE RENAL INSUFFICIENCY. IMPOSSIBILITY OF KNOWING THE EXACT QUANTITY OF PRODUCT INJECTED. LOSS OF TIME. HAVING TO RE-INJECT PATIENTS TO PLACE A NEW CATHETER".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16763350 ↗MalfunctionApr 7, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED WHILE USING BD CATHENA SAFETY IV CATHETER LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE ANTI-REFLUX VALVE CAUSES AN OVERPRESSURE DURING THE INJECTIONS AT THE CT (INJECTION AT 4-5 CC/SEC) CAUSING: A LEAK ON THE 3-WAY VALVE; EXPLOSION OF THE TUBING; POOR SCANNER INJECTION MAKING DIAGNOSIS DIFFICULT; RISK OF BLOOD EXPOSURE ACCIDENT FOR THE MER WHO HAVE TO CLEAN UP AFTERWARDS THIS PROBLEM OCCURS WITH MOST OF THE CATHETERS USED, IT DOES NOT SEEM TO AFFECT ONLY ONE BATCH. CONSEQUENCES : LEAK ON THE 3-WAY VALVE; EXPLOSION OF THE TUBING; POOR SCANNER INJECTION MAKING DIAGNOSIS DIFFICULT; RISK OF BLOOD EXPOSURE ACCIDENT FOR THE MER WHO HAVE TO CLEAN UP AFTERWARDS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16698882 ↗MalfunctionDec 6, 2022Material Protrusion/Extrusion; Material Protrusion/Extrusion
IT WAS REPORTED THAT THE BD CATHENA¿ SAFETY IV CATHETER WITH WINGS AND BD MULTIGUARD¿ TECHNOLOGY WOULD NOT ACTIVATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: WHEN THE NURSE WAS CANNULATING, SHE REFERS THAT THE SECURITY SYSTEM DID NOT ACTIVATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15928835 ↗MalfunctionAug 19, 2022Leak/Splash; Defective Component; Leak/Splash; Defective Component
IT WAS REPORTED THAT WHILE USING A BD CATHENA¿ SAFETY IV CATHETER WITH WINGS AND BD MULTIGUARD¿ TECHNOLOGY, BLOOD LEAKED FROM THE BLOOD CONTROL VALVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: ANTI-RETURN VALVE DEFECT ON VENOUS KIT, SOILING OF PANTS AND SNEAKERS. DURING THE INSTALLATION OF THE LEFT FOREARM VENOUS KIT FOR THE PREPARATION OF THE EXAM ON (B)(6), BLOOD RETURNED DESPITE THE ANTI-RETURN VALVE IN THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15260138 ↗MalfunctionAug 3, 2022Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT 1 BD CATHENA¿ SAFETY IV CATHETER WITH WINGS AND BD MULTIGUARD¿ TECHNOLOGY HAD NEEDLE THROUGH CATHETER WHILE INTRODUCING THE CATHETER ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM BASQUE TO ENGLISH : "AFTER THE CANNULA DOES NOT ADVANCE, THE DUE MAKES A SMALL BACKWARD MOVEMENT TO RECANALIZE AND IN THE SECOND ADVANCE THERE IS RESISTANCE SO DECIDES TO REMOVE THE CANNULA AND FINDING AT IT'S EXIT THAT THE NEEDLE HAD PERFORATED THE CATHETER."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15160971 ↗MalfunctionMay 21, 2021Material Protrusion/Extrusion; Material Protrusion/Extrusion
IT WAS REPORTED THAT THE SAFETY DEVICE ON THE BD CATHENA¿ SAFETY IV CATHETER WITH WINGS AND BD MULTIGUARD¿ TECHNOLOGY DID NOT ENGAGE WHEN THE NEEDLE WAS REMOVED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: "SECURED CATHETER, WHOSE SAFETY DEVICE DOES NOT ENGAGE WHEN THE NEEDLE IS REMOVED. RISK OF PUNCTURE/EXPOSURE TO BLOOD".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11866229 ↗MalfunctionApr 28, 2021Material Protrusion/Extrusion; Material Protrusion/Extrusion
IT WAS REPORTED THAT CATHENA 20GX1.25IN WINGED BC HAD A SAFETY MECHANISM FAILURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ADDITIONAL INFORMATION (B)(6)2021: THERE WAS NO NEEDLE STICK INJURY. SAFETY MECHANISM OF THE NEEDLE NOT ACTIVATED, STILL UNCLEAR WHETHER THERE HAS BEEN A NEEDLESTICK INJURY. NOTIFICATION VIA EMAIL: AFTER REMOVING THE IV NEEDLE FROM THE CANNULA, THE SAFETY MECHANISM DID NOT ACTIVATE, ON DEPARTMENT EMERGENCY!
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11742543 ↗MalfunctionDec 3, 2020Retraction Problem; Retraction Problem
IT WAS REPORTED THAT THE BD CATHENA¿ SAFETY IV CATHETER EXPERIENCED A NEEDLE THAT WOULD NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLE THAT DOES NOT RETRACT ONCE REMOVED FROM THE CATHETER.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10939336 ↗InjuryNov 26, 2020Break; Leak/Splash; Break; Leak/Splash
IT WAS REPORTED THAT WHEN THE BD CATHENA¿ SAFETY IV CATHETER WITH WINGS BD MULTIGUARD¿ TECHNOLOGY WAS REMOVED FROM THE PATIENT, THE END OF THE CATHETER BROKE OFF AND REMAINED IN THE VEIN. AN INCISION WAS PERFORMED BY A HAND SURGEON TO REMOVE THE BROKEN PIECE, AND AN ECHO-DOPPLER WAS PERFORMED THE DAY AFTER THE INCIDENT. NO FURTHER COMPLICATIONS WERE REVEALED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: WHEN A 20G PERIPHERAL CATHETER WAS PLACED IN A SEPSIS PATIENT, THE CATHETER COULD NOT BE MOUNTED, SO IT WAS REMOVED. WHEN THE CATHETER WAS REMOVED, A RESISTANCE APPEARED AND ONE END OF THE PLASTIC OF THE CATHETER WAS CUT AND REMAINED IN THE VEIN. CLINICAL CONSEQUENCES OBSERVED: INCISION IN THE CHAMBER TO RETRIEVE THE FOREIGN MATERIAL ON A SEPTIC PATIENT. UPDATE NOVEMBER 6: INDEED THE CATHETER DID COME INTO CONTACT WITH BLOOD AND CHEMOTHERAPY PRODUCTS BECAUSE THE INCIDENT OCCURRED DURING THE PATIENT'S CHEMO TREATMENT. CONCERNING THE CONSEQUENCES, ACCORDING TO THE FILE A HAND SURGEON HAD TO INTERVENE TO REMOVE THE PIECE THAT REMAINED IN THE PATIENT, AN ECHO-DOPPLER WAS PERFORMED THE DAY AFTER THE INCIDENT (30/10), WHICH DID NOT REV
Patient problems: Foreign Body In Patient
MAUDE report 10909837 ↗InjuryNov 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT EXTRAVASATION OCCURRED WHILE USING CATHENA 20GX1.25IN WINGED BC. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VVP DIFFUSION LEFT ELBOW BEND 1 HOUR AFTER INSTALLATION (WITH NEW CATHLON). CÉFAZOLINE WAS IN PROGRESS. NO REDNESS.
Patient problems: Extravasation
MAUDE report 10827036 ↗InjuryNov 11, 2020Material Protrusion/Extrusion; Material Protrusion/Extrusion
IT WAS REPORTED THAT CATHENA 20GX1.25IN WINGED BC HAD A RETRACTION FAILURE AND CAUSED A NEEDLE STICK INJURY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING THE INSTALLATION OF A VVP, THE KT DID NOT RETRACT AUTOMATICALLY WHEN I WANTED TO REMOVE IT I PRICKED MYSELF WITH THE KT.
Patient problems: Exposure to Body Fluids; Needle Stick/Puncture
MAUDE report 10824122 ↗MalfunctionAug 6, 2020Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BLOOD LEAKED FROM THE BD CATHENA¿ SAFETY IV CATHETER WITH WINGS BD MULTIGUARD¿ TECHNOLOGY DURING THE INSERTION WHILE REMOVING THE NEEDLE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 4TH OF 4 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN INTRODUCING THE ABOVE CATHLON INTO PATIENT¿S VEIN THE PLASTIC CATHLON WILL NOT MOVE FORWARD CAUSING THE VEIN TO BLOW. ON A NUMBER OF OCCASIONS BLOOD FLOW ON INSERTION WHEN REMOVING THE NEEDLE OCCURS. ON 13 JULY A PATIENT WAS IN FOR A REGULAR INFUSION AND 2 ATTEMPTS WITH ABOVE WAS UNSUCCESSFUL. USED AN OLD CATHLON AND IT WENT STRAIGHT IN. I FIND MANY NURSES ARE ATTEMPTING A NUMBER OF STARTS THAT FAIL. THIS IS NOT SAFE FOR PATIENTS AS WELL AS NURSING STAFF, ALSO TIME CONSUMING AND COSTLY."
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10376669 ↗MalfunctionJul 14, 2020Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE BD CATHENA¿ SAFETY IV CATHETER WITH WINGS BD MULTIGUARD¿ TECHNOLOGY VALVE LEAKED BLOOD DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 3RD OF 4 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THESE NEW CATHETERS ARE EXTREMELY DIFFICULT TO USE. THEY DO NOT THREAD AFTER A BLOOD FLASH HAS BEEN SEEN. THE FAILURE RATE WITH THESE CATHETERS IS HIGH. THE VALVE OFTEN LEAKS. WHEN ATTEMPTING TO DRAW LABS (ESPECIALLY ON PEDIATRIC PATIENTS) THE VALVE PREVENTS THIS AND RESULTS IN A SECOND INVASIVE PROCEDURE ON A CHILD. THIS IS A DRAMATICALLY INFERIOR PRODUCT."
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10269543 ↗MalfunctionJul 8, 2020Leak/Splash; Leak/Splash
IT WAS REPORTED THAT WHEN DISPOSING THE BD CATHENA¿ SAFETY IV CATHETER WITH WINGS BD MULTIGUARD¿ TECHNOLOGY NEEDLE, BLOOD SPLASHED OFF THE SHAFT AND ONTO THE NURSE'S FACE. THERE WAS NO REPORT OF INJURY OR EXPOSURE TO THE MUCOUS MEMBRANE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE BLOOD SPLASHED WHEN THE NEEDLE WAS BEING DISPOSED OF, AS THERE WAS BLOOD ON THE SECURED NEEDLE SHAFT, WHICH BENT WHILE BEING PUT IN THE SHARPS BIN, AND IT FLICKED BLOOD ON THE NURSE¿S FACE. WITH THE EXPOSED NEEDLE HAVING BLOOD ON IT, AND THE FLIMSY AND UNPROTECTED DESIGN OF THE UNIT, THERE SEEMS TO BE A LOT OF CONCERN AND REPORTS ABOUT HIGHER RISK TO STAFF." "UNABLE TO ADVANCE CATHETER, STIFF. BLOOD EXPOSED ON OPEN NEEDLE. UNABLE TO USE IV, NEW IV REQUIRED."
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10248636 ↗
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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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