BD Cathena Safety IV Catheter 386813Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00382903868131), received between Jun 12, 2019 and Jun 17, 2026 — classified as 1 injury, 17 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 17, 2026Activation Failure

  "IT WAS REPORTED THAT STAFF MEMBER REPORTS SUSTAINING A NEEDLESTICK INJURY DUE TO INCOMPLETE ENCAPSULATION OF THE NEEDLE TIP. AFFECTED PRODUCT WAS DISPOSED OF. NIL FURTHER HAS BEEN NOTICED OR REPORTED WITH THIS BATCH ON SITE, THERE IS NO CONCERN OVER TECHNIQUE IN USE ALSO."

  Patient problems: Needle Stick/Puncture

  MAUDE report 25535569 ↗
• MalfunctionJun 27, 2025Break; Complete Blockage; Break; Complete Blockage

  IT WAS REPORTED THAT BD CATHENA 22GX1.00IN WINGED BC ADAPTER / CONNECTOR WAS DEFECTIVE / DAMAGED WHAT HAPPENED/COULD HAVE HAPPENED? WE DISCOVER THAT THE THREE-WAY TAP HAS BROKEN AND THAT SOMETHING IS STUCK IN THE PVK. THE PVK HAS BEEN SET BY THE ANAESTHETIST, SO WE ARE A LITTLE UNSURE OF WHAT IT SHOULD LOOK LIKE. 3 WAY VALVE IS BROKEN AND SOMETHING GOT STUCK IN THE PIVC WHEN DID THE INCIDENT OCCUR - DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22346381 ↗
• MalfunctionMar 24, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT BD CATHENA 22GX1.00IN WINGED BC NEEDLE SHIELDING FAILED I WOULD LIKE TO INFORM YOU OF AN INCIDENT INVOLVING A 22G CATHETER - REFERENCE 386813, BATCH NUMBER 4178005 - EXP 30/06/2027. DESCRIPTION OF THE INCIDENT: DURING THE INSERTION OF A 22GA CATHETER IN A PATIENT, I NOTICED WHEN REMOVING THE MANDREL THAT THE SAFETY SYSTEM HAD NOT BEEN PUT IN PLACE. DATE OF INCIDENT: (B)(6)2025 LOCATION: UNIT 2C - CLB UNFORTUNATELY, THE CATHETER WAS NOT PRESERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21681779 ↗
• MalfunctionMay 30, 2024Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT BD CATHENA 22GX1.00IN WINGED BC NEEDLE CLOGGED / BLOCKED IMPOSSIBLE TO DRAW BLOOD OUT OF THE CATHETER 22G IMPOSSIBLE TO DRAW BLOOD OUT OF THE CATHETER HUB IN USING VACUTIANER TUBE. BY THE WAY, THERE IS NO ISSUE TO INJECT SOMETHING IN USING THE CATHETER HUB. IS THAT DUE TO THE MULTIGUARD VALVE AND THE FORCE WHICH IS REDUCED BY VACUTAINER TUBE? WHEN DID THE INCIDENT OCCUR? DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19424950 ↗
• InjuryMay 30, 2023Defective Component; Defective Component

  IT WAS REPORTED THAT THE BD CATHENA¿ SAFETY IV CATHETER WITH WINGS BD MULTIGUARD¿ TECHNOLOGY WAS DAMAGED AND CAUSED A SKIN LESION ON THE PUNCTURE SITE WHEN REMOVED. AS A RESULT, THE PATIENT DEVELOPED PHLEBITIS, BUT NO FURTHER INFORMATION WAS PROVIDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PROBLEM OF PLACING NEW CATHETERS ON PERIPHERAL VENOUS LINES. AGGRESSIVE CATHETERS ON THE SKIN IN PEOPLE WITH A PRECARIOUS VENOUS CAPITAL WITH OR WITHOUT CORTICOIDS. A SKIN LESION HAS BEEN OBSERVED AT THE PUNCTURE SITE WITH VENITIS WHEN THE CATHETER IS REMOVED. RECURRENT PROBLEM IN SEVERAL PATIENTS. GREATER RISK OF INFECTION WITH AND WITHOUT VENOUS THROMBOSIS."

  Patient problems: Vasculitis

  MAUDE report 17025757 ↗
• MalfunctionOct 29, 2022Leak/Splash; Detachment of Device or Device Component; Leak/Splash; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE HUB OF THE BD CATHENA¿ SAFETY IV CATHETER WITH WINGS BD MULTIGUARD¿ TECHNOLOGY WAS DEFECTIVE AND DISCONNECTED FROM THE INFUSION SET'S LUER-LOCK CONNECTION DURING USE, CAUSING FLUID TO LEAK AS A RESULT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH: "DISCONNECTION AND FLUID LEAKAGE AT THE JUNCTION OF THE CATHETER HUB WITH THE LUER LOCK CONNECTION OF THE INFUSION SET OR EXTENSION SET. DISCONNECTION AND FLUID LEAKAGE AT THE JUNCTION OF THE CATHETER HUB WITH THE LUER LOCK CONNECTION OF THE INFUSION SET. DURING USE"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15696407 ↗
• MalfunctionOct 10, 2022Leak/Splash; Detachment of Device or Device Component; Leak/Splash; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BD CATHENA¿ SAFETY IV CATHETER WITH WINGS BD MULTIGUARD¿ TECHNOLOGY LUER CONNECTION SEPARATED FROM THE MATING COMPONENT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: "CATHETER FITTED ON 8.09 WITHOUT DIFFICULTY TO A 15 YEAR OLD WHO WAS NOT MOVING ON THE MORNING OF 09.09, THE EXTENDER HAD BECOME LOOSE WITHOUT ANYONE HAVING TOUCHED IT. WE SCREWED THE EXTENDER ON TIGHTLY WHEN WE INSTALLED IT CONSEQUENCES: EXTENSION SCREWED UP, RISK OF INFECTION . ACTIONS TAKEN: REMOVAL OF THE DEVICE AND DISPOSAL"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15573053 ↗
• MalfunctionJul 15, 2022Defective Component; Defective Component

  IT WAS REPORTED THAT THE SAFETY MECHANISM DID NOT ACTIVATE WHILE USING THE BD CATHENA¿ SAFETY IV CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: WHEN REMOVING THE NEEDLE FROM A PATIENT, THE SAFETY SYSTEM DID NOT ACTIVATE.

  Patient problems: Needle Stick/Puncture

  MAUDE report 15034093 ↗
• MalfunctionAug 19, 2021Break; Break

  IT WAS REPORTED THAT THE BD CATHENA¿ SAFETY IV CATHETER EXPERIENCED A DAMAGED CATHETER TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IN THE CONTEXT OF AN MRI-EXAMINATION THE PATIENT REPORTED UNUSUAL HEAT PAIN AT THE ARM EXACTLY WHERE THE CATHETER WAS PLACED. AFTER CHECKING THE CANNULA I NOTICED IT HAS A METAL COIL.

  Patient problems: Pain

  MAUDE report 12345523 ↗
• MalfunctionApr 5, 2021Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT 2 BD CATHENA¿ SAFETY IV CATHETERS EXPERIENCED A SAFETY MECHANISM THAT WOULD NOT ACTIVATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 2 PERIPHERAL VENOUS CATHETERS IN A ROW DO NOT AUTOMATICALLY SECURE THEMSELVES AUTOMATICALLY AFTER PUNCTURING THE VEIN AND REMOVING THE MANDREL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11616806 ↗
• MalfunctionJan 7, 2021Leak/Splash; Device Contamination with Chemical or Other Material; Leak/Splash; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT CATHENA 22GX1.00IN WINGED BC WAS DAMAGED AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NEW BLUE CATHETERS CAUSE BLOOD TO STAGNATE IN THE AREA JUST EMERGING FROM THE PUNCTURE SITE. THIS IS AN INFECTIOUS RISK. TO LIMIT THE RISK OF INFECTION, THE NURSES HAVE TO CHANGE THESE CATHETERS SOMETIMES DAILY, CAUSING PAIN AND DISCOMFORT FOR THE PATIENTS AND INCREASING THE RISK OF INFECTION FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11131272 ↗
• MalfunctionAug 7, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT CATHENA 22GX1.00IN WINGED BC WILL NOT MOVE FORWARD CAUSING THE PATIENT'S VEIN TO BLOW AND BLOOD TO FLOW. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 386813 BATCH NO: UNKNOWN. IT WAS REPORTED THAT DURING PATIENTS INFUSION, WHEN INTRODUCING THE ABOVE CATHLON INTO PATIENT¿S VEIN THE PLASTIC CATHLON WILL NOT MOVE FORWARD CAUSING THE VEIN TO BLOW, BLOOD FLOW ON INSERTION WHEN REMOVING THE NEEDLE OCCURS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10382566 ↗
• 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 4TH 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 10269549 ↗
• MalfunctionJul 7, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT CATHENA 22GX1.00IN WINGED BC BLOOD CONTROL SAFETY FEATURE FAILED. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 386813 BATCH NO: 8116294 IT WAS REPORTED THAT BLOOD CONTROL SAFETY FAILED ON PRACTICE WET ARM THE CUSTOMER REPORTS THIS HAS BEEN OCCURRING WITH PATIENT INSERTIONS. QUESTIONS/INQUIRIES: PHOTOS OF SCENARIO AND/OR FAILED PRODUCT? I DO NOT HAVE PICTURES AT THIS TIME. IT IS LIKELY THAT WE CAN REPRODUCE THE ISSUE IF YOU REQUEST IT. CAN YOU DESCRIBE THE FAILURE? IS IT FAILING AT THE CATHENA CATHETER OR FROM THE GUARD BELOW THE WINGS? EVEN WITH APPROPRIATE IV INSERTION TECHNIQUE, WE WILL HAVE BLOOD RETURN FROM THE END OF THE CATHETER WHERE WE WOULD ATTACH THE IV TUBING. THE BLOOD PENETRATES BEYOND THE BLOOD CONTROL MECHANISM. THIS WAS PRODUCED ON A ¿WET ARM¿ WHERE THERE WAS ONLY MODERATE PRESSURE AND NO ACTUAL LIVING BLOOD PRESSURE.

  Patient problems: No Patient Involvement

  MAUDE report 10242681 ↗
• MalfunctionJun 1, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT CATHENA 22GX1.00IN WINGED BC HAD DIFFICULT ENGAGING THE THREADS ON THE CATHETER. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 386813 BATCH NO: UNKNOWN. IT WAS REPORTED THAT IT IS DIFFICULT TO ENGAGE THE THREADS ON THE CATHETER TO FLUSH CATHETER. THREADING OF LUER LOK POOR DESIGN. USER REQUIRED TO FORCE END OF FLUSH INTO CATHETER TO ENGAGE THREADS. DESIGN SHOULD BE - INSERT AND THREAD, THEN SPRING ENGAGES AFTER 15 DEGREE ROTATION, INSTEAD OF THE NECESSITY OF DEPRESSING THE SPRING INITIALLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10107361 ↗
• MalfunctionMay 22, 2020Leak/Splash; Retraction Problem; Leak/Splash; Retraction Problem

  IT WAS REPORTED THAT DURING USE, THE BD CATHENA¿ SAFETY IV CATHETER WITH WINGS AND BD MULTIGUARD¿ TECHNOLOGY WAS DIFFICULT TO ATTACH TO THE SALINE LOCK, AND DIFFICULT TO DETACH THE VACUTAINER FROM THE IV. THE "HEPLOK" WAS DIFFICULT TO SCREW ON, THE CAP WAS DIFFICULT TO ATTACH, AND THE CATHETER WAS DIFFICULT TO DISCONNECT FROM THE HUB, NEEDING BOTH HANDS TO DO SO. ADDITIONALLY, IT WAS REPORTED THAT THE SAFETY MECHANISM BECAME STUCK, "BINDING" IN ON ITSELF WHEN ATTEMPTING TO ADVANCE THE CATHETER. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 3 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DATE OF INCIDENT (YYYY-MM-DD): (B)(6) 2020 INCIDENT DETAILS: HERE IS A SUMMARY OF THE REPORTED CONCERNS / ISSUES; EACH WERE EXPRESSED IN MULTIPLE REPORTS: ¿ HARD TO ADVANCE. DIFFICULT TO ADVANCE WITHOUT BLOWING PATIENT VEIN (REQUIRES MORE ATTEMPTS ON PATIENT). ¿ VERY DIFFICULT ATTACHING TO SALINE LOCK. DIFFICULT TO DETACH VACUTAINER FROM IV CATHETER. CAN'T SCREW ON HEPLOK. HARD TO DISCONNECT HUB FROM CATHETER. HARD TO ATTACH CAP. ¿ PROBLEMS THREADING ANGIO / DIFFICULTY SCREWING LOCK ONTO ANGIO. ¿ MULTIPLE ATTEMPTS TO START IV. MISSED IV'S. ¿ DIFFICULT TO FIN

  Patient problems: No Code Available

  MAUDE report 10083749 ↗
• MalfunctionJun 12, 2019Leak/Splash; Device Contamination with Chemical or Other Material; Leak/Splash; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DAMAGE OCCURRED WITH A CATHENA 22GX1.00IN WINGED BC. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "WE ARE CONTINUING TO HAVE ISSUES WITH CATHETERS DISCONNECTING AND HAVING TO BE REPLACED WHEN THEY CLOT. WE ARE CURRENTLY USING LOT 8116294, AND I'VE HAD SEVERAL COMPLAINTS RELATED TO THIS PARTICULAR LOT. WE ARE NOTICING THAT THE CATHETER STYLETS SEEM TO BE VERY DULL, AND IT IS REQUIRING MULTIPLE ATTEMPTS TO PLACE A CATHETER. IN SOME CASES IT HAS REQUIRED MULTIPLE LIMBS AND MULTIPLE TECHNICIANS, AND THEY HAVE STILL NOT BEEN SUCCESSFUL WITH CATHENA, BUT GET IT IN INSTANTLY WITH AN INSYTE. THE 22G X 1" SEEM TO BE THE MAJOR ISSUE BUT ARE ALSO THE ONES WE ARE USING WITH MOST REGULARITY."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8692937 ↗
• MalfunctionJun 12, 2019Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE CATHENA 22GX1.00IN WINGED BC SAFETY SHIELD REMAINED STUCK IN THE TRANSPARENT SLEEVE DURING USE, LEAVING THE NEEDLE EXPOSED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: AS PART OF THE CATHENA CATHETER TESTS, I ENCOUNTERED A PROBLEM DURING THE SAFETY OF THE NEEDLE. THE WHITE PART WHICH IS SUPPOSED TO COVER THE SHARP PART OF THE NEEDLE, REMAINED STUCK IN THE TRANSPARENT SLEEVE DURING THE SECURITY OF THE NEEDLE. LEAVING THE SHARP PART OF THE NEEDLE COMPLETELY ACCESSIBLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8691486 ↗