BD Cathena Safety IV Catheter 386803Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00382903868032), received between Mar 8, 2019 and Jan 6, 2026 — classified as 1 injury, 27 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (9 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 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 6, 2026Activation Problem

  IT WAS REPORTED THAT BD US CATHENA 20GX1.25IN STRAIGHT BC SAFETY MECHANISM FAILED. IT WAS REPORTED BY THE CUSTOMER THAT ABLE TO DISENGAGE THE SAFETY WHILE STARTING THE IV. WHEN HE ADDS IMMENSE PRESSURE TO THE CATHETER HUB, THE SAFETY MAKES AN AUDIBLE CLICK SOUND, AND THE SAFETY IS DEACTIVATED. WHEN HE THREADS THE CATHETER THE GRAY SAFETY MECHANISM STAYS INSIDE THE CLEAR CANNULA. WHEN HE PULLS BACK ON THE NEEDLE UPON THREADING, THE NEEDLE IS EXPOSED. VERBATIM: NURSE WAS ABLE TO DISENGAGE THE SAFETY WHILE STARTING THE IV. WHEN HE ADDS IMMENSE PRESSURE TO THE CATHETER HUB, THE SAFETY MAKES AN AUDIBLE CLICK SOUND, AND THE SAFETY IS DEACTIVATED. WHEN HE THREADS THE CATHETER THE GRAY SAFETY MECHANISM STAYS INSIDE THE CLEAR CANNULA. WHEN HE PULLS BACK ON THE NEEDLE UPON THREADING, THE NEEDLE IS EXPOSED. ADDITIONAL INFO RECEIVED ON 30-DEC: LOT # 5081570, LOT # 5096085. ONE NURSE WAS INJURED FROM A NEEDLE STICK AFTER PLACING AN IV. THEY BELIEVED THAT THE SAFETY HAD ACTIVATED BUT WHEN THEY WENT TO PUT THROW AWAY THE SHARP THEY WERE POKED. A NURSE ON A DIFFERENT FLOOR PLACED AN IV AND STATED THAT THE SAFETY DID NOT ENGAGE, THEY NOTICED THE ISSUE AND NO INJURY OCCURRED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 23974666 ↗
• MalfunctionJun 26, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT BD CATHENA 20GX1.00IN STRAIGHT BC CATHETER BROKE / SEPARATED BEFORE PLACEMENT IT WAS REPORTED BY THE CUSTOMER THAT PT WAS A VERY HARD IV START, WRITER WAS ABLE TO GET IV AND THEN WHEN I WAS UNATTACHING THE NEEDLE FROM THE CATHLON THE WHITE PLASTIC PLUNGER POPPED OUT OF THE CATHLON END. WHEN YOU ATTEMPT TO ATTACH THE IV FLUID TUBING, NOTHING WILL FLOW. THEREFORE, THE CATHLON HAD TO BE REMOVED AS IT WOULD NOT WORK. WRITER DID NOT ATTEMPT TO RESTART IV AND LEFT IT FOR THE ANESTHETIST TO DO. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. INCIDENT OR PROBLEM INFORMATION. AHS MDIP REFERENCE NUMBER (ID): (B)(4). DATES OF INCIDENT (YYYY-MM-DD): (B)(6) 2025. SITE NAME/LOCATION: (B)(6). LEVEL OF HARM: HAZARD. XXX OPTIONAL REPORT TO CMDSNET (HEALTH CANADA): INCIDENT DETAILS: PT WAS A VERY HARD IV START, WRITER WAS ABLE TO GET IV AND THEN WHEN I WAS UNATTACHING THE NEEDLE FROM THE CATHLON THE WHITE PLASTIC PLUNGER POPPED OUT OF THE CATHLON END. WHEN YOU ATTEMPT TO ATTACH THE IV FLUID TUBING, NOTHING WILL FLOW. THEREFORE, THE CATHLON HAD TO BE REMOVED AS IT WOULD NOT WORK. WRITER DID NOT ATTEMPT TO RESTART IV AND LEFT IT FOR THE ANESTHETIST TO DO. DEVICE INFORMATION DEVICE N

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22341140 ↗
• MalfunctionJun 7, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT BD CATHENA 20GX1.00IN STRAIGHT BC HAD FOREIGN MATTER DESCRIPTION OF THE ANOMALY: HARDWARE DEFECT - WHILE CHECKING THE MEDICAL DEVICE BEFORE USE, THE RADIOGRAPHER BECAME AWARE OF THE PRESENCE OF PLASTIC FRAGMENTS ON THE CATHETER. THERE WERE NO CLINICAL CONSEQUENCES FOR THE PATIENT. THE OFFENDING DEVICE HAS BEEN PRESERVED AND IS CURRENTLY IN QUARANTINE. WOULD YOU LIKE TO COLLECT THE DEVICE FOR EXPERTISE OR ARE THE ATTACHED PHOTOS ENOUGH FOR YOU?" IN ADDITION, SINCE THIS INCIDENT LED TO THE USE OF ANOTHER UNIT OF THE SAME SYSTEM, WOULD IT BE POSSIBLE TO BENEFIT FROM A FREE UNIT?

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22164033 ↗
• MalfunctionMay 29, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT BD CATHENA 20GX1.00IN STRAIGHT BC CATHETER WAS DEFECTIVE / DAMAGED IT WAS REPORTED BY CUSTOMER THAT THE "WHITE PART" IN THE CENTER PORTION OF THE CATHETER OF THE PINK HUB IS "POPPING OUT," VERBATIM: RN REPORTED THAT THE "WHITE PART" IN THE CENTER PORTION OF THE CATHETER OF THE PINK HUB IS "POPPING OUT".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22109369 ↗
• MalfunctionApr 24, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT BD CATHENA 20GX1.00IN STRAIGHT BC BLOOD LEAK OUT OF CONTROL PLUG. IT WAS REPORTED BY CUSTOMER THAT THE BLOOD WAS LEAKING FROM IV CATHETER ONCE INSERTED, PRIOR TO CONNECTION TO TUBING. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. INCIDENT OR PROBLEM INFORMATION AHS MDIP REFERENCE NUMBER (ID): (B)(4), DATE OF INCIDENT (YYYY-MM-DD): (B)(6) 2025. TYPE OF INCIDENT/PROBLEM: FAILURE (I.E. WHILE PREPARING FOR, IN USE, AFTER USE) LEVEL OF HARM: NO APPARENT HARM - REACHED THE PATIENT/PERSON -- INCONVENIENT AHS OPTIONAL REPORT TO CMDSNET (HEALTH CANADA): INCIDENT DETAILS: IV CATHETERS ARE SUPPOSED TO HAVE STOPPER THAT DOES NOT ALLOW BLOOD FLOW ONCE IV CATHETHER INSERTED, PRIOR TO CONNECTION TO TUBING. MULTIPLE INCIDENTS OF STOPPER NOT WORKING IN THIS PARTICULAR LOT. NURSING USED TO NOT HAVE TO COMPRESS VEIN POST INSERTION BUT NOW HAVING TO REVERT TO PRACTICE. EVERY EPISODE IS FROM THIS LOT NUMBER. WHO WAS AFFECTED? PATIENT DEVICE INFORMATION DEVICE NAME/DESCRIPTION: CATHETER IV SAFETY NON-WINGED WITH MULTIGUARD 20GAX1.00IN CATHENA, MANUFACTURER: BECTON DICKINSON CANADA INC, MANUFACTURER CODE/MODEL: 386803 SERIAL OR LOT NUMBER: (B)(6), SUPPLIER: XXX SUPPLIER/CATALOGUE NUM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21900945 ↗
• MalfunctionMar 21, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD CATHENA 20GX1.00IN STRAIGHT BC LEAKED IT WAS REPORTED BY CUSTOMER THAT THEY ENCOUNTER OCCASIONAL PROBLEM WITH THE PRODUCT 386803 AND BATCH 4148272. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. A REQUESTER INFORMS ME OF AN OCCASIONAL PROBLEM WITH THE PRODUCT 386803 HAVING THE BATCH # OF 4148272.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21668135 ↗
• MalfunctionMar 6, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT BD US CATHENA 20GX1.00IN STRAIGHT BC NEEDLE SHIELDING FAILED   IT WAS REPORTED BY CUSTOMER THAT SAFETY (WHITE PIECE) COMPLETELY DETACHED FROM THE NEEDLE, LEAVING THE SHARP EXPOSED   VERBATIM: SAFETY (WHITE PIECE) COMPLETELY DETRACTED FROM THE NEEDLE, LEAVING THE SHARP EXPOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21537137 ↗
• MalfunctionJan 2, 2025Break; Break

  IT WAS REPORTED THAT BD CATHENA 20GX1.00IN STRAIGHT BC SAFETY SHIELD ACTIVATION FAILED. WHILE PULLING THE CLEAR CHAMBER, SHE FELT A RESISTANCE AND WHEN SHE FINALLY RETRACTED IT SHE FELT THE SAFETY CAP BROKE AND FAIL TO BE ENGAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21060533 ↗
• MalfunctionJul 5, 2023Defective Device; Defective Device

  IT WAS REPORTED WHILE USING BD CATHENA SAFETY IV CATHETER THE SAFETY MECHANISM DID NOT PROPERLY ENGAGE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SAFETY DID NOT ENGAGE WHEN INSERTING CATHENA. IT HAPPENED WITH 2 20G THAT WERE FROM THE SAME LOT# AS WELL AS AN 18G.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17260127 ↗
• MalfunctionApr 26, 2023No Flow; No Flow

  IT WAS REPORTED WHILE USING BD CATHENA SAFETY IV CATHETER THERE WAS A BLOCKAGE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON MARCH 29, RN REPORTED THAT TWICE ON THEIR SHIFT THERE WAS A MALFUNCTION IN THE IV CATHETER. THE CATHETER WAS INSERTED AND BLOOD RETURN FLOW WAS OBSERVED AND NEEDLE WAS REMOVED. ONCE THE CATHETER WAS ATTACHED TO THE IV TUBINGS AND STARTED INFUSION, THERE WAS RESISTANCE. IV WAS DISCONNECTED AND SYRINGE WAS USED IN ATTEMPT TO TEST WHETHER THERE WAS RESISTANCE. IV WAS REMOVED SUBSEQUENTLY AND RESITED. ANOTHER INCIDENT EXPERIENCED BY ANOTHER NURSE WITH A DIFFERENT LOT NUMBER WITH SIMILAR INCIDENT. THE LATTER EVENTUALLY WORKED. ONE OTHER INCIDENT REPORTED BY DR. IN OR. SIMILAR INCIDENT, RESISTANT. IT APPEARS ON ALL THE INCIDENTS THAT THE SPRING MALFUNCTION INSIDE THE IV CATHETER. THE ABOVE INCIDENTS HAPPENED SPORADICALLY USING THE SAME LOT NUMBERS ON MARCH 28 & 29. STORES WAS CONSULTED BUT NO OTHER AVALIABLE LOT NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16820917 ↗
• MalfunctionApr 26, 2023Failure to Deliver; Failure to Deliver

  IT WAS REPORTED WHILE USING BD CATHENA SAFETY IV CATHETER THERE WAS A BLOCKAGE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON MARCH 29, RN REPORTED THAT TWICE ON THEIR SHIFT THERE WAS A MALFUNCTION IN THE IV CATHETER. THE CATHETER WAS INSERTED AND BLOOD RETURN FLOW WAS OBSERVED AND NEEDLE WAS REMOVED. ONCE THE CATHETER WAS ATTACHED TO THE IV TUBINGS AND STARTED INFUSION, THERE WAS RESISTANCE. IV WAS DISCONNECTED AND SYRINGE WAS USED IN ATTEMPT TO TEST WHETHER THERE WAS RESISTANCE. IV WAS REMOVED SUBSEQUENTLY AND RESITED. ANOTHER INCIDENT EXPERIENCED BY ANOTHER NURSE WITH A DIFFERENT LOT NUMBER WITH SIMILAR INCIDENT. THE LATTER EVENTUALLY WORKED. ONE OTHER INCIDENT REPORTED BY DR. IN OR. SIMILAR INCIDENT, RESISTANT. IT APPEARS ON ALL THE INCIDENTS THAT THE SPRING MALFUNCTION INSIDE THE IV CATHETER. THE ABOVE INCIDENTS HAPPENED SPORADICALLY USING THE SAME LOT NUMBERS ON MARCH 28 & 29. STORES WAS CONSULTED BUT NO OTHER AVAILABLE LOT NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16820915 ↗
• MalfunctionJul 26, 2022Retraction Problem; Defective Component; Retraction Problem; Defective Component

  IT WAS REPORTED WHILE USING BD CATHENA SAFETY IV CATHETER THE SAFETY MECHANISM FAILED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PLACED ON A PATIENT, WHEN THE NEEDLE IS WITHDRAWN, THE SAFETY DEVICE IS NOT ENGAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15108735 ↗
• MalfunctionMar 14, 2022Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED WHILE USING BD CATHENA SAFETY IV CATHETER THE SAFETY MECHANISM DID NOT ACTIVATE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CATHETER DID NOT SECURE ITSELF AT THE TIME OF REMOVAL, NO ACCIDENT TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13762762 ↗
• MalfunctionMar 1, 2022Fail-Safe Problem; Fail-Safe Problem

  IT WAS REPORTED WHILE USING BD CATHENA SAFETY IV CATHETER THE SAFETY MECHANISM FAILED AND DID NOT DEPLOY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FUNCTIONAL PROBLEM AT THE LEVEL OF THE SAFETY OF THE CATHETER, AT THE TIME OF THE INSTALLATION OF INFUSION AT THE TIME OF WITHDRAWING THE NEEDLE, THE SAFETY WAS NOT FUNCTIONAL: RISK OF ACCIDENT OF EXPOSURE TO BLOOD (AES) - BARE NEEDLE. NO ACCIDENT TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13638808 ↗
• MalfunctionDec 20, 2021Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE SAFETY MECHANISM ON THE BD CATHENA¿ SAFETY IV CATHETER WITH BD MULTIGUARD¿ TECHNOLOGY FAILED TO ACTIVATE AND LEFT THE DIRTY NEEDLE EXPOSED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6): "FUNCTIONAL PROBLEM WITH THE SAFETY OF THE CATHETER, DURING THE INFUSION WHEN REMOVING THE NEEDLE, THE SAFETY WAS NOT FUNCTIONAL: RISK OF BLOOD EXPOSURE ACCIDENT (BEE) - BARE NEEDLE. NO ACCIDENT TO REPORT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13048236 ↗
• MalfunctionDec 15, 2021Break; Break

  IT WAS REPORTED THAT THE BD CATHENA INTRAVASCULAR CATHETER EXPERIENCED THE NEEDLE PIERCING THROUGH THE CATHETER DURING CATHETER INTRODUCTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DEFECTIVE CATHETER AT TIME OF VENOUS ACCESS. FOLLOWING THE RECOMMENDATIONS FOR USE, IN PREPARATION, HELD THE BASEPLATE AND MOVED THE CATHETER FORWARD ABOUT 3MM AND RETURNED IT TO ITS ORIGINAL POSITION, A PIECE OF CATHETER APPEARED AT THE TIP OF THE NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13009950 ↗
• MalfunctionJul 15, 2021Break; Material Protrusion/Extrusion; Break; Material Protrusion/Extrusion

  IT WAS REPORTED THAT CATHENA 20GX1.00IN STRAIGHT BC CATHETER SEPARATED AND THE SAFETY MECHANISM WOULD NOT ACTIVATE ON 2 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON 2 OCCASIONS, DURING THE CARE CARRIED OUT BY THE NURSE THE SECURE KT DID NOT RETRACT FOLLOWING THE INSTALLATION OF THE INFUSION LEAVING THE NEEDLE APPEAR. DURING A BLOOD SAMPLE AT THE TIME OF THE CATHETER INSTALLATION AND THE VACUTAINER DELIVERY, THE VACUTAINER ADAPTER DISADAPTS FROM THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12173725 ↗
• MalfunctionOct 13, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE CATHENA 20GX1.00IN STRAIGHT BC LEAKED. THIS COMPLAINT WAS CREATED TO CAPTURE THE 3RD OF 3 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CT MANAGER SENT EMAIL EXPRESSING THEY ARE EXPERIENCING FREQUENT CONTRAST EXTRAVASATION EVENTS IN CT DEPT. FOR THE MOST PART USING 18G FOR HIGH FLOW RATE INJECTIONS, TEST IV'S PRIOR TO BEING HOOKED UP TO PUMP. SOME CT UNITS ARE ALSO USING 20G FOR ALL THEIR INJECTIONS."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10668522 ↗
• MalfunctionMar 31, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A CONNECTION ISSUE OCCURRED WITH A CATHENA 20GX1.00IN STRAIGHT BC. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "DIFFICULTY IN CONNECTING THE 3-WAY TAP INFUSION SET AND THE BLEEDING SET AND UNTIMELY DISCONNECTION OF THE LINES. THE INFUSION LINE DISCONNECTS AFTER A FEW HOURS. THE BLEEDING TUBING: IMPOSSIBLE TO PERFORM THE BLEEDING, WERE FORCED TO PERFORM THE BLEEDING FROM A SYRINGE."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9908153 ↗
• MalfunctionFeb 19, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD CATHENA SAFETY IV CATHETER BD MULTIGUARD TECHNOLOGY 20 GA 1.00 IN HAD A LEAK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THERE'S A HOLE ABOUT 3MM FROM THE GUARD. THE INFUSED FLUID PASSES THROUGH THIS HOLE AND NOT INTO THE VENOUS CATHETER. REMOVING THE MATERIAL AND INSERTING A NEW CATHETER."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9727977 ↗
• MalfunctionJun 28, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND BEFORE USE WITH A CATHENA 20GX1.00IN STRAIGHT BC. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "USER NOTICED A SMALL PLASTIC PIECE ON THE NEEDLE BEFORE USE."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8744478 ↗
• InjuryMay 21, 2019Break; Leak/Splash; Material Protrusion/Extrusion; Break; Leak/Splash; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE NEEDLE DETACHED AND BLOOD LEAKED AND SAFETY MECHANISM FAILED THUS CAUSING USER TO HAVE BLOOD SPLASH ON FACE AND EYES WITH A BD CATHENA¿ 20GX1.00IN STRAIGHT BC. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DESCRIPTION FROM PARAMEDIC; "I HAVE TRIED TO RECALL TO THE BEST OF MY ABILITY A REPLICATE OF HOW THE CANNULA CAME APART. I DO REMEMBER THAT IT WAS REPORTED THAT AS SOON AS MY COLLEAGUE INSERTED THE CANNULA THE BLOOD STARTED TO LEAK OUT THE SIDE BETWEEN THE PINK AND WHITE PART IMMEDIATELY BEFORE ANYTHING ELSE HAD BEEN REMOVED. THAT¿S WHEN SHE ASKED FOR MY ASSISTANCE. THE CANNULA HAD THEN ALREADY BROKEN INTO 3 PARTS BUT ALSO SOMEHOW STILL HELD TOGETHER AND INSITU (THIS IS THAT PART THAT I AM HAVING DIFFICULTY REMEMBERING THE MOST). THEN I DO RECALL THAT I WAS HOLDING ONTO THE PINK HUB WHILST MY PARTNER ATTEMPTED TO REMOVE THE SHARP AND WHITE PART HOWEVER THE SHARP DETACHED COMPLETELY FROM THE WHITE PART AND WHEN IT CAME OUT OF THE WHITE PART IT SEEMED TO HAVE PRESSURE OF IT SO FLICKED BLOOD UP INTO MY FACE INCLUDING INTO MY EYES. THE SHARP WAS COMPLETELY EXPOSED AT THIS POINT.

  Patient problems: Exposure to Body Fluids

  MAUDE report 8628646 ↗
• MalfunctionMay 16, 2019Break; Break

  IT WAS REPORTED THAT THE CATHENA 20GX1.00IN STRAIGHT BC EXPERIENCED NEEDLE BREAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER; STAFF MEMBER WAS PREPPING TO CANNULATE & NOTICED IT LOOKED ODD. THE VERY TIP OF THE CANNULA CAME OFF WHEN SHE REMOVED THE STYLET. THE PIECE IS ONLY A FRACTION OF A MILLIMETER. IT MAY STILL BE IN THE PACKAGING.

  Patient problems: No Patient Involvement

  MAUDE report 8616911 ↗
• MalfunctionApr 1, 2019Break; Material Separation

  IT WAS REPORTED THAT A BD CATHENA¿ 20GX1.00IN STRAIGHT BC HAD A NEEDLE BREAK. THE FOLLOWING WAS REPORTED, "MATERIAL NO: 386803 BATCH NO: 8086304. IT WAS REPORTED THAT HUB AND NEEDLE SEPARATED FROM THE CATHETER STAYING IN THE PATIENT. PER INCIDENT REPORT: PATIENT WAS EARLY 50S, FORMER IV DRUG USER, HAD GOOD VEIN IN RIGHT AC, PUT TOURNIQUET ON, SUCCESSFUL ACCESS, ADVANCED THE CATHETER, WHEN PULLED BACK, PINK HUB CAME BACK WITH THE NEEDLE RESULTING IN CATHETER SEPARATING FROM THE HUB AND STAYING IN THE PATIENT. XXXXXX THEN PINCHED END OF CATHETER THAT WAS STICKING OUT OF PATIENT'S ARM TO REMOVE IT. THEN APPLIED PRESSURE AND GAUZE, ALCOHOL SWAB AND CLEANED WORK AREA DUE TO BLOOD EXPOSURE."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8471605 ↗
• MalfunctionMar 13, 2019Leak/Splash

  IT WAS REPORTED THAT A CATHENA 20GX1.00IN STRAIGHT BC LEAKED. THE REPORT IS AS FOLLOWS, "ON 8 OUT OF 9 CATHETERS, THE ANTI-REFLUX VALVE FAILED. IT WAS LEAKING UPON INSERTION 3 INCIDENTS OCCURRED ON (B)(6) AND THEN THERE WERE OTHERS THAT OCCURRED ON AN UNKNOWN DATE HAPPENED ON DIFFERENT PATIENTS BUT THEY DID NOT HAVE TO RE-STICK THE PATIENTS EACH TIME BECAUSE THE IV WAS STILL FUNCTIONAL" THIS COMPLAINT IS TO CAPTURE THE ADDITIONAL EVENTS ON AN UNKNOWN DATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8418600 ↗