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BD Cathena Safety IV Catheter 386808Recalls & reported problems

Becton, Dickinson And Company · CATHENA 18GX1.25IN 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 winged safety IV catheter is a short-term intravenous line placed into a vein. The 31 reports mostly describe leaking or splashing at the insertion site, blood or fluid leaking from the tubing and valve, and a needle that would not retract after use; a few mention small bits of plastic at the catheter tip and contrast leaking out of the vein during CT scans. No deaths and no injuries were reported, and 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
31
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00382903868087), received between Dec 20, 2018 and Apr 28, 2026 — classified as 31 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (21 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

Nov 2023: 1 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 1 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 1 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Leak/Splash21
  • Difficult or Delayed Activation2
  • Fluid/Blood Leak2
  • Material Protrusion/Extrusion2
  • Retraction Problem2
  • Contamination1
  • Contamination /Decontamination Problem1
  • Incorrect, Inadequate or Imprecise Result or Readings1

Patient problems

  • No Consequences Or Impact To Patient12
  • No Clinical Signs, Symptoms or Conditions8
  • No Patient Involvement4
  • No Known Impact Or Consequence To Patient3
  • Extravasation1
  • Insufficient Information1
  • No Code Available1
  • Pain1

Recent adverse event reports

The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 28, 2026Contamination /Decontamination Problem

    IT WAS REPORTED BY CUSTOMER THAT THERE APPEARS TO BE SOME SORT OF SUBSTANCE NOTICED IN THE CANULA AND PROTRUDES FROM THE TIP OF THE CANULA WHEN ENSURING SEPARATION OF CANULA AND NEEDLE PRIOR TO USE ON PATIENTS. SOME DEVICES ARE NOT SHARP ENOUGH TO PIERCE SKIN. COMPLAINT VIA EMAIL. XXXXX MDIP REPORT INCIDENT OR PROBLEM INFORMATION XXXXX MDIP REFERENCE NUMBER (ID): (B)(4) DATE OF INCIDENT (YYYY-MM-DD): (B)(6) 2026 TYPE OF INCIDENT/PROBLEM: A1. DEFECT (OBSERVED PRIOR TO USE) LEVEL OF HARM: NO EFFECT - DID NOT REACH PATIENT/PERSON -- DETECTED BEFORE USE OR DOES NOT TOUCH PATIENT BEFORE USE XXXXX OPTIONAL REPORT TO CMDSNET (HEALTH CANADA): INCIDENT DETAILS: THERE APPEARS TO BE SOME SORT OF SUBSTANCE NOTICED IN THE CANULA AND PROTRUDES FROM THE TIP OF THE CANULA WHEN ENSURING SEPARATION OF CANULA AND NEEDLE PRIOR TO USE ON PATIENTS. SOME DEVICES ARE NOT SHARP ENOUGH TO PIERCE SKIN. DEVICE INFORMATION DEVICE NAME/DESCRIPTION: CATHETER IV SAFETY WINGED WITH MULTIGUARD 18GAX1.25IN CATHENA MANUFACTURER: BECTON DICKINSON CANADA INC MANUFACTURER CODE/MODEL: 386808 SERIAL OR LOT NUMBER: 4278305 SUPPLIER: XXXXX SUPPLIER/CATALOGUE NUMBER: 333-386808 IS THE DEVICE RETAINED?

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25017437 ↗
  • MalfunctionApr 3, 2025Contamination; Contamination

    IT WAS REPORTED THAT BD CATHENA 18GX1.25IN WINGED BC HAD CATHETER TIP INTEGRITY THE TIP OF THE CATHETER HAS A SMALL PIECE OF PLASTIC THAT IS ATTACHED TO THE REST OF THE CATHETER BY A THREAD. WHEN YOU MOVE IT, IT COMES OFF. WHEN DID THE INCIDENT OCCUR? BEFORE USE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21768241 ↗
  • MalfunctionNov 1, 2023Leak/Splash; Leak/Splash

    HERE ARE THE BATCH NUMBERS CURRENTLY IN USE: 3111826 ; 2299806 ; 2312531. I DON'T HAVE ANY PHOTOS TO PROVIDE. CONSEQUENCES: EXTRAVASATION OF CONTRAST MEDIUM. IN SOME CASES, RADIOLOGY HAS BEEN PERFORMED TO VISUALIZE THE EXTRAVASATION.

    Patient problems: Extravasation

    MAUDE report 18051929 ↗
  • MalfunctionOct 20, 2023Fluid/Blood Leak; Fluid/Blood Leak

    IT WAS REPORTED THE BD CATHENA 18GX1.25IN WINGED BC LEAKED . THE FOLLOWING INFORMATION WAS PROVIDED TO THE INITIAL REPORTER: "BLOOD LEAKED AFTER PLACEMENT DURING USE."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17981583 ↗
  • MalfunctionAug 1, 2023Retraction Problem; Retraction Problem

    IT WAS REPORTED THAT THE BD CATHENA¿ SAFETY IV CATHETER WITH WINGS BD MULTIGUARD¿ TECHNOLOGY NEEDLE WOULD NOT RETRACT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "COULD NOT RETRACT NEEDLE FROM BD CATHENA. NEEDLE WOULD NOT SAFETY, LEAVING NEEDLE AND CATHETER ATTACHED TOGETHER."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17438336 ↗
  • MalfunctionApr 14, 2023Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

    IT WAS REPORTED THAT THE BD CATHENA¿ SAFETY IV CATHETER WITH WINGS BD MULTIGUARD¿ TECHNOLOGY TUBING BURST DURING THE INJECTION AND LEAKED AS A RESULT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: "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: Insufficient Information

    MAUDE report 16746033 ↗
  • MalfunctionApr 13, 2023Leak/Splash; Leak/Splash

    IT WAS REPORTED THAT THE BD CATHENA¿ SAFETY IV CATHETER WITH WINGS BD MULTIGUARD¿ TECHNOLOGY LEAKED CONTRAST MEDIA DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: "WHEN INJECTING CONTRAST MEDIA (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 16740477 ↗
  • MalfunctionJul 28, 2021Leak/Splash; Leak/Splash

    IT WAS REPORTED THAT THE BD CATHENA SAFETY IV CATHETER WITH WINGS BD MULTIGUARD TECHNOLOGY 18 GA 1.25 IN EXPERIENCED BLOOD LEAKAGE THROUGH THE BC VALVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ONCE CATHETER INSERTED AND NEEDLE REMOVED, THE ONE WAY VALVE DID NOT STOP BLEEDING AND BECAUSE THEY ARE SUPPOSED TO BE BLOODLESS, WE WERE NOT ABLE TO EFFECTIVELY TAMPONADE IT ABOVE SITE TO STOP ALL BLEEDING. LEVEL OF HARM: NO APPARENT HARM - REACHED PATIENT/PERSON.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12239524 ↗
  • MalfunctionMay 14, 2021Material Protrusion/Extrusion; Material Protrusion/Extrusion

    IT WAS REPORTED THAT THE BD CATHENA SAFETY IV CATHETER WITH WINGS BD MULTIGUARD TECHNOLOGY 18 GA 1.25 IN EXPERIENCED A SAFETY MECHANISM THAT WOULD NOT ACTIVATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON AN INSTALLATION OF VVP (PERIPHERAL VENOUS ROUTE), DURING THE WITHDRAWAL, THE NEEDLE WAS NOT SECURED. MAJOR RISK OF EXPOSURE TO BLOOD. THE BLOOD STOP VALVE HAS WORKED. THERE WERE NO CONSEQUENCES FOR EITHER THE PATIENT OR THE STAFF AS WE IMMEDIATELY NOTICED THE MALFUNCTION AND TOOK OUR PRECAUTIONS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11829609 ↗
  • MalfunctionMar 10, 2021Material Protrusion/Extrusion; Material Protrusion/Extrusion

    IT WAS REPORTED THAT THE BD CATHENA SAFETY IV CATHETER WITH WINGS BD MULTIGUARD TECHNOLOGY 18 GA 1.25 IN EXPERIENCED A SAFETY MECHANISM THAT WOULD NOT ACTIVATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER SPECIFICALLY, I WOULD LIKE TO REPORT AN INCIDENT THAT OCCURRED ON A CATHETER DURING A DEMONSTRATION; IN OTHER WORDS, IT HAPPENED WITH ME, WITH ONE OF MY CATHETERS AND NOT TO A CLIENT. DURING THE DEMONSTRATION OF A GREEN CATHENA CATHETER ON A DEMONSTRATION VEIN, THE CATHETER DID NOT GO INTO SAFETY. FOR THE REST THE CATHENA BEHAVED NORMALLY (THE MULTIGUARD STOPPED THE BLOOD, THE VARIOUS REFLUXES WERE PRESENT). SAMPLE NOT SET ASIDE. NO EFFECT ON PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11458114 ↗
  • MalfunctionAug 11, 2020Leak/Splash; Leak/Splash

    IT WAS REPORTED THAT BD CATHENA SAFETY IV CATHETER WITH WINGS BD MULTIGUARD TECHNOLOGY LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT A BLOOD LEAKAGE WAS DRIPPING OUT THE BACK OF THE CATHETER. AHS MDIP REPORT INCIDENT OR PROBLEM INFORMATION AHS MDIP REFERENCE NUMBER (ID): 5012 DATE OF INCIDENT (YYYY-MM-DD): (B)(6). 2020. SITE NAME/LOCATION: CARDSTON EMS LEVEL OF HARM: NO APPARENT HARM - REACHED PATIENT/PERSON, INCONVENIENT AHS OPTIONAL REPORT TO CMDSNET (HEALTH CANADA): NO INCIDENT DETAILS: WAS USING THE BD CATHENA SAFETY IV CATHETER THAT IS BLOODLESS AS PER AHS POLICY AND PROCEDURE. ONCE THE SHARP WAS REMOVED BLOOD CONTINUED TO FLOW OUT OF THE BACK OF CATHETER, DRIPPING ON TO FLOOR AND MY UNIFORM AND ALSO DOWN THE PATIENT'S ARM. WHO WAS AFFECTED? PATIENT DEVICE INFORMATION DEVICE NAME/DESCRIPTION: CATHETER IV SAFETY WINGED WITH MULTIGUARD 18GAX1.25IN CATHENA MANUFACTURER: BECTON DICKINSON CANADA INC MANUFACTURER CODE/MODEL: (B)(4). SERIAL OR LOT NUMBER: 8116292 SUPPLIER: THE STEVENS COMPANY LTD SUPPLIER CATALOGUE NUMBER: 333-386808 WAS THE DEVICE RETAINED? NO. INVESTIGATION REQUEST EXPECTED TYPE OF INVESTIGATION: LOT REVIEW, REPORT HI

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10394391 ↗
  • 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 3RD 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 10376656 ↗
  • MalfunctionJul 14, 2020Leak/Splash; Leak/Splash

    IT WAS REPORTED THAT BD CATHENA SAFETY IV CATHETER WITH WINGS BD MULTIGUARD TECHNOLOGY LEAKED THROUGH THE VALVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT: (CATHETER IV SAFETY WINGED WITH MULTIGUARD 18GAX1.25IN CATHENA)THEY DO NOT THREAD AFTER A BLOOD FLASH HAS BEEN SEEN AND THE VALVE OFTEN LEAKS. EVENT DESCRIPTION PER ATTACHED EMAIL STATES: 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. QUESTIONS/INQUIRIES RELATED TO 18GAX1.25IN CATHENA. -NO DEVICE(S) RETAINED? PHOTOS OF PRODUCT? PHOTOS OF BOXES/PACKAGING? -INCIDENT DATE? WHAT DAY WAS THIS ISSUE RECORDED/DISCOVERED? -IS REPRESENTATIVE SAMPLE (UNUSED PRODUCT FROM SAME LOT) AVAILABLE?"

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10274297 ↗
  • MalfunctionJun 2, 2020Difficult or Delayed Activation

    IT WAS REPORTED THAT BD CATHENA SAFETY IV CATHETER WITH WINGS BD MULTIGUARD TECHNOLOGY 18 GA 1.25 IN SAFETY MECHANISM WAS DIFFICULT TO REMOVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE CATHETER IS DIFFICULT TO ADVANCE WITHOUT BLOWING VEINS, FLASHBACK IS POOR AND CAN'T TELL IF STILL IN VEIN, DIFFICULT TO DISCONNECT AND PATIENTS WERE COMPLAINING OF MORE PAIN THAT USUAL. EVENT DESCRIPTION PER ATTACHED EMAIL STATES: INSERTION SEEMS MORE PAINFUL TO PATIENTS. DIFFICULT TO ADVANCE. "BLOWS" VEIN. CAN'T TELL BY BLOOD FLOW IF CATH IS STILL IN VEIN. DIFFICULT TO DISCONNECT (NEED 2 HANDS). DIFFICULT TO ATTACH TO SALINE SET. "

    Patient problems: No Patient Involvement

    MAUDE report 10112278 ↗
  • MalfunctionJun 2, 2020Leak/Splash; Leak/Splash

    IT WAS REPORTED THAT BD CATHENA SAFETY IV CATHETER WITH WINGS BD MULTIGUARD TECHNOLOGY 18 GA 1.25 IN HAD A CONNECTER THAT COULD NOT ATTACH TO THE MATING COMPONENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE CATHETER IS DIFFICULT TO ADVANCE WITHOUT BLOWING VEINS, HARD TO ATTACH IV TUBING TO HUB AND PATIENTS WERE COMPLAINING OF MORE PAIN THAT USUAL. EVENT DESCRIPTION PER ATTACHED EMAIL STATES: AHS MDIP # 3339 / MANUFACTURER CODE/MODEL: 386808. DATE OF INCIDENT (YYYY-MM-DD): (B)(6)2020. DIFFICULT TO ADVANCE WITHOUT BLOWING PATIENT VEIN (REQUIRES MORE ATTEMPTS ON PATIENT). HARD TO ATTACH IV EXTENSION TUBING TO HUB OF IV CATHETER. PATIENTS SEEM TO FIND THEM MORE PAINFUL THAN USUAL."

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10112229 ↗
  • MalfunctionJun 2, 2020Difficult or Delayed Activation; Difficult or Delayed Activation

    IT WAS REPORTED THAT BD CATHENA SAFETY IV CATHETER WITH WINGS BD MULTIGUARD TECHNOLOGY 18 GA 1.25 IN HAD A SAFETY MECHANISM THAT IS DIFFICULT TO ACTIVATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT VEINS ARE BLOWING WHEN THE CATHETER IS ADVANCED AND DIFFICULTIES DISCONNECTING THE CATHETER HAVE BEEN ENCOUNTERED. EVENT DESCRIPTION PER ATTACHED EMAIL STATES: IV CATHETER DIFFICULT TO USE, GOOD FLASH BACK THEN BLOWS WHEN ADVANCED. DIFFICULT TO DO WHEN YOU NEED TO HOLD TENSION ON THE SKIN WHEN INSERTING BECAUSE YOU HAVE TO USE 2 HAND WHEN DISCONNECTING. WHEN IN AN EMERGENCY SITUATION IT WOUND NOT BE GOOD. ".

    Patient problems: No Patient Involvement

    MAUDE report 10112174 ↗
  • MalfunctionJun 2, 2020Leak/Splash

    IT WAS REPORTED THAT BD CATHENA SAFETY IV CATHETER WITH WINGS BD MULTIGUARD TECHNOLOGY 18 GA 1.25 IN HAD AN ADAPTER UNABLE TO CONNECT TO THE MATING COMPONENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE CATHETER IS DIFFICULT TO ADVANCE AND DIFFICULT TO ATTACH TO SALINE LOCK. EVENT DESCRIPTION PER ATTACHED EMAIL STATES: HARD TO ADVANCE AND ATTACH TO SALINE LOCK. MULTIPLE ATTEMPTS TO START IV.".

    Patient problems: No Patient Involvement

    MAUDE report 10112167 ↗
  • MalfunctionJun 2, 2020Leak/Splash; Leak/Splash

    IT WAS REPORTED THAT BD CATHENA SAFETY IV CATHETER WITH WINGS BD MULTIGUARD TECHNOLOGY 18 GA 1.25 IN CONNECTOR WAS NOT ABLE TO CONNECT TO THE MATING COMPONENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE CATHETER IS DIFFICULT TO ADVANCE, DIFFICULT TO ATTACH SALINE LOCK AND PATIENTS WERE COMPLAINING OF MORE PAIN THAT USUAL. EVENT DESCRIPTION PER ATTACHED EMAIL STATES: HARD TO ADVANCE. HARD TO ATTACH SALINE LOCK. PAINFUL (OR SEEMS MORE PAINFUL) TO PATIENT-BASED ON THEIR FEEDBACK. MISSED IV, MULTIPLE ATTEMPTS TO INITIATE."

    Patient problems: No Patient Involvement

    MAUDE report 10112154 ↗
  • MalfunctionJun 2, 2020Leak/Splash

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD CATHENA SAFETY IV CATHETERS WITH WINGS BD MULTIGUARD TECHNOLOGY 18 GA 1.25 IN EXPERIENCED AN INABILITY FOR THE CATHETER ADAPTER/HUB TO CONNECT WITH THE MATING COMPONENT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 386808 ,BATCH NO: UNKNOWN. EVENT DESCRIPTION: DIFFICULT TO THREAD: VERY DIFFICULT TO ATTACH SALINE LOCK; DIFFICULT TO ANCHOR WHILE WITHDRAWING NEEDLE; DIFFICULT TO SEE/SLOW FLASH.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10111495 ↗
  • MalfunctionJun 2, 2020Leak/Splash

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD CATHENA SAFETY IV CATHETERS WITH WINGS BD MULTIGUARD TECHNOLOGY 18 GA 1.25 IN WERE UNABLE TO CONNECT THE CATHETER ADAPTER/HUB WITH THE MATING COMPONENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 386808, BATCH NO: UNKNOWN. EVENT DESCRIPTION: DIFFICULT TO FIND OUT IF WE ARE IN VEIN. CAN¿T SCREW ON HEP LOK. BLOOD HEMOLYZING.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10107525 ↗
  • MalfunctionJun 2, 2020Leak/Splash

    IT WAS REPORTED THAT THE LOCK WAS DIFFICULT TO SCREW ONTO THE CATHENA 18GX1.25IN WINGED BC DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PROBLEMS THREADING IV. PROBLEMS SCREWING LOCK."

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10107522 ↗
  • MalfunctionJun 2, 2020Leak/Splash

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD CATHENA SAFETY IV CATHETER WITH WINGS BD MULTIGUARD TECHNOLOGY 18 GA 1.25 IN EXPERIENCED AN INABILITY FOR THE CATHETER ADAPTER/HUB TO CONNECT WITH THE MATING COMPONENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 386808, BATCH NO: UNKNOWN. EVENT DESCRIPTION: DIFFICULTY SCREWING ON SALINE FLUSH. SLOWER TO SHOW "FLASH". DIFFICULTY THREADING IN VEIN.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10107521 ↗
  • MalfunctionJun 1, 2020Leak/Splash

    IT WAS REPORTED THAT THE SALINE FLUSH WAS DIFFICULT TO ATTACH TO TO THE CATHENA 18GX1.25IN WINGED BC DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "VERY HARD TO THREAD CATHETER INTO VEIN. VERY DIFFICULT TO ATTACH TO SALINE FLUSH. HARD TO SEE FLASH. OVERALL VERY AWKWARD TO USE.".

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10107507 ↗
  • MalfunctionJun 1, 2020Leak/Splash

    IT WAS REPORTED THAT THE SALINE FLUSH WAS DIFFICULT TO ATTACH TO TO THE CATHENA 18GX1.25IN WINGED BC DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "VERY HARD TO THREAD. DIFFICULT TO ATTACH SALINE FLUSH. HARD TO SEE FLASH. HARD TO USE.".

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10107504 ↗
  • MalfunctionJun 1, 2020Leak/Splash; Leak/Splash

    IT WAS REPORTED THAT CATHENA 18GX1.25IN WINGED BC CATHETER IS HAVING DIFFICULT THREADING. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 386808 BATCH NO: UNKNOWN. IT WAS REPORTED THAT THE CATHETER IS DIFFICULT TO THREAD AND DIFFICULT TO SCREW ONTO LUER LOCK.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 10107383 ↗

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