BD Cathena Safety IV Catheter 386801Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00382903868018), received between Sep 7, 2018 and Jul 14, 2025 — classified as 2 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Contamination” (5 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 14, 2025Contamination; Contamination

  IT WAS REPORTED THAT BD CATHENA 18GX1.25IN STRAIGHT BC HAD FOREIGN MATTER ON ASSESSMENT, THE CANNULAS APPEAR TO HAVE A CLEAR RESIDUE OR FLAKE ON THE CUTTING EDGE (ANTERIOR BEVEL). THIS RESIDUE RAISES CONCERNS ABOUT STERILITY AND POSSIBILITY TO AFFECT THE EFFECTIVENESS OF THE CANNULAS DURING USE. ACTION: ACTIONS TAKEN INCLUDE CONDUCTING A THOROUGH INSPECTION OF THE AFFECTED CANNULAS TO CONFIRM THE PRESENCE OF RESIDUE ON THE ANTERIOR BEVEL. THE FINDINGS WERE RECORDED, INCLUDING PRODUCT DETAILS, BATCH NUMBERS, AND PHOTOGRAPHS OF THE AFFECTED CANNULAS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22495681 ↗
• MalfunctionJul 11, 2025Contamination; Contamination

  IT WAS REPORTED THAT BD CATHENA 18GX1.25IN STRAIGHT BC HAD FOREIGN MATTER MENTIONED ON A CALL THAT FSH HAD OPENED A BOX OF CANNULA'S AND 5 WERE AFFECTED WITH THE EXCESS SILICON AT THE TIP AS PART OF THEIR DILIGENT MONITORING OF CATHENA CANNULA'S.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22480880 ↗
• MalfunctionJul 9, 2025Contamination; Contamination

  IT WAS REPORTED THAT BD CATHENA 18GX1.25IN STRAIGHT BC HAD FOREIGN MATTER CATHENA CANNULA WITH SUBSTANCE INSIDE TIP OF DEVICE. ON RETRACTION OF STYLET, CUSTOMER NOTICED VISIBLE SUBSTANCE ON INSIDE OF CANNULA NEAR TIP OF DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22459392 ↗
• MalfunctionJul 8, 2025Contamination; Contamination

  IT WAS REPORTED THAT BD CATHENA 18GX1.25IN STRAIGHT BC HAD FOREIGN MATTER I AM CONTACTING YOU TO REPORT A PROBLEM ENCOUNTERED WHEN USING TWO OF YOUR PRODUCTS: PRODUCT DESCRIPTION: SHORT PERIPHERAL SAFETY CATHETER 18G 32MM, REFERENCE: 386801, BATCH NUMBER: 4278310, PRODUCT DESCRIPTION: SHORT PERIPHERAL SAFETY CATHETER 18G 32MM, REFERENCE: 386801, BATCH NUMBER: 4278310, DESCRIPTION OF THE ANOMALY: MATERIAL DEFECT. - WHEN CHECKING THESE TWO MEDICAL DEVICES BEFORE USE ON WEDNESDAY (B)(6) 2025, THE RADIO OPERATOR NOTICED PLASTIC FRAGMENTS ON THE CATHETERS. INITIALLY VISIBLE ON THE SURFACE, THESE FRAGMENTS HAVE MOVED AND ARE NOW TRAPPED INSIDE THE CATHETER PROTECTION. THIS IS THE THIRD INCIDENT WITH THIS REFERENCE. THE DEVICES IN QUESTION HAVE BEEN RETAINED AND ARE CURRENTLY IN QUARANTINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22436905 ↗
• MalfunctionJun 4, 2024Contamination; Contamination

  IT WAS REPORTED THAT BD CATHENA 18GX1.25IN STRAIGHT BC SMALL PIECE OF PLASTIC OR GLUE STUCK INSIDE THE BEVEL OF CANNULA. SMALL PIECE OF PLASTIC OR GLUE STUCK INSIDE THE BEVEL OF CANNULA. HSS HAS RECEIVED A PRODUCT COMPLAINT FROM (B)(4) HOSPITAL, SEE PRODUCT DETAIL BELOW: PRODUCT: BD CATHENA 18GA 1.25 IN. SUPPLIER: (B)(4). COMPLAINT: ["STERILITY/CONTAMINATION OR LEAKAGE ISSUE","MANUFACTURING FAULT?"] DESCRIPTION: SMALL PIECE OF PLASTIC OR GLUE STUCK INSIDE THE BEVEL OF CANNULA. ACTION: DISCARDED AND USED DIFFERENT ITEM AND INSPECTED FOR FOREIGN MATERIAL. TOOK PHOTOS OF PRODUCT THEN DISCARDED. COMPLAINANT: (B)(6). CONTACT NUMBER: (B)(6). ALTERNATIVE CONTACT: (B)(6). IS PRODUCT AVAILABLE? NO. IS PACKAGING AVAILABLE? NO. WE REQUEST A SOLUTION TO THIS COMPLAINT, ALONG WITH REPLACEMENT PRODUCTS OR A CREDIT REIMBURSEMENT BY THE KPI DEADLINE OF 11 JUNE 2024. ALL COMMUNICATIONS REGARDING THIS ISSUE SHOULD ALSO BE EMAILED TO MAILTO:HSS.(B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19462176 ↗
• MalfunctionMar 2, 2023Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT THE BD CATHENA¿ SAFETY IV CATHETER WAS DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: A KINK FORMED ON THE CATHETER, WHICH WAS PLACED IN THE ELBOW CREASE, DUE TO MOVEMENT. AFTER REMOVAL, OBSERVATION OF THE CATHETER REVEALED A PERFORATION AT THE LEVEL OF THE KINK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16475479 ↗
• InjuryAug 11, 2022Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT THE BD CATHENA¿ SAFETY IV CATHETER BROKE INSIDE THE PATIENT'S VEIN. PATIENT REQUIRED SURGERY TO REMOVE BROKEN PIECE. THE FOLLOWING INFORMATION WAS PROVIDE BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH: "BROKEN CATHETER INSIDE THE VEIN...LATER THE PATIENT REPORTED PAIN IN HER ARM AND UNDERWENT SURGERY TO REMOVE THE CATHETER."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15211177 ↗
• InjuryMar 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED WHILE USING BD CATHENA SAFETY IV CATHETER WITH BD MULTIGUARD TECHNOLOGY BLOOD COULD NOT BE DRAWN FROM THE CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHAT WAS THE LEVEL OF HARM?: HARM OR CLINICALLY SERIOUS ADVERSE EVENT MULTIPLE PERIPHERAL IV'S IN PLACE EACH IV CATHETER WAS A STYLE THAT REDUCES BACKFLOW OF BLOOD WITH SMALL WHITE STOPPERS IN THE HUB. WERE UNABLE TO DRAW A VBG EITHER BY VENIPUNCTURE (PHYSIOLOGY OF PT) OR FROM IV CATHETER SITES. THE PATIENT HAD A CLINICAL DETERIORATION OF WHICH WE COULD NOT MONITOR POINT OF CARE BLOOD WORK . WHO WAS AFFECTED? PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 13877735 ↗
• MalfunctionMay 14, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT CATHENA 18GX1.25IN STRAIGHT BC HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHERE RESISTANCE WAS FELT ON LOOSENING THE CATHETER & THE SMALL FRAGMENTS OF PLASTIC WERE SEEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11829250 ↗
• MalfunctionOct 13, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE CATHENA 18GX1.25IN STRAIGHT BC LEAKED DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST 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 10668517 ↗
• MalfunctionMar 31, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT IT WAS DIFFICULT TO CONNECT THE INFUSION LINE, AND THEN IT DISCONNECTS AFTER A TIME WITH A BD CATHENA¿ SAFETY IV CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: 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.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9907251 ↗
• MalfunctionNov 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT HAS BEEN REPORTED THAT ONE BD CATHENA¿ SAFETY IV CATHETER HAS BEEN FOUND EXPERIENCING EXTRAVASATION DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: A DR INSERTED A CATHENA CANNULA FOR AN IRON INFUSION. THE IRON INFUSION HAS STAINED THE ARM OF THE PATIENT (WHICH IS LIKELY TO BE PERMANENT) ? DUE TO EXTRAVASATION. THE DR DID NOT RECEIVE EDUCATION ON HOW TO USE CANNULA PRIOR TO USE.

  Patient problems: Extravasation

  MAUDE report 9309198 ↗
• MalfunctionSep 24, 2019Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT BD CATHENA¿ SAFETY IV CATHETER NEEDLE DID NOT RETRACT ALL THE WAY. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 386801; BATCH NO.: 8144026. IT WAS REPORTED THAT THE NEEDLE DID NOT RETRACT ALL THE WAY LEAVING THE NEEDLE EXPOSED. PER COMPLAINT FORM: CLINICAL RESOURCE NURSE CONTACTED ME VIA EMAIL AND SENT IN PICTURES OF CATHENA SHOWING THAT THE NEEDLE DID NOT FULLY RETRACT LEAVING THE NEEDLE EXPOSED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9111606 ↗
• MalfunctionJul 10, 2019Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT DURING USE THE SAFETY MECHANISM FAILED, WHICH RESULTED IN EXPOSED NEEDLE WITH A BD CATHENA¿ SAFETY IV CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE SAFETY MECHANISM FAILED TO ACTIVATE RESULTING IN AN EXPOSED NEEDLE. PER INITIAL COMPLAINT: LOT NUMBER UNKNOWN AT THIS POINT BUT MANAGER IS TRYING TO LOCATE FROM INTERNAL "SIMS" REPORT. TRAUMA PATIENT CAME INTO THE ER FROM A CAR ACCIDENT, WAS COMMUNICATED THAT PATIENT HAD EXCELLENT VASCULAR ACCESS, ATTEMPTED TO INSERT AN 18G CATHENA IN UPPER RIGHT ARM OR HAND (HE DOES NOT RECALL LOCATION OF INSERTION), PROCEEDED TO INSERT THE IV, PUSHED THE GREEN HUB FORWARD AND PULLED BACK ON THE STYLET WHEN THE NEEDLE BECAME EXPOSED AND THE SAFETY MECHANISM FAILED TO ACTIVATE RESULTING IN AN EXPOSED NEEDLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8776630 ↗
• MalfunctionMar 22, 2019Leak/Splash

  IT WAS REPORTED THAT A BD CATHENA¿ SAFETY IV CATHETER HAD LEAKAGE. THE FOLLOWING WAS REPORTED, "HEALTH CARE PROFESSIONAL INSERTED AN 18G IN PATIENT'S HAND, ELDERLY LADY WHO WAS COOPERATIVE, GOT INSTAFLASH, THEN REMOVED TOURNIQUET, HEARD THE CLICK OF THE "SAFETY MECHANISM" WITH CLICK, BLOOD THEN SPLATTERED UP THE ARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8444368 ↗
• MalfunctionMar 1, 2019Leak/Splash

  IT WAS REPORTED THAT DURING USE OF THE BD CATHENA¿ SAFETY IV CATHETER THE 18G CATHETER HAD SOME FLICK AT THE END OF WITHDRAWAL TIME, BLOOD SPRAYED UP ON MEDIC'S ARM.

  Patient problems: Exposure to Body Fluids

  MAUDE report 8381891 ↗
• MalfunctionFeb 18, 2019Device Slipped

  IT WAS REPORTED WITH THE USE OF THE BD CATHENA¿ SAFETY IV CATHETER THERE WAS AN ISSUE WITH SILVER METAL BIT FLEW OUT ONTO THE PREP AREA WHEN THE NEEDLE WAS REMOVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8348680 ↗
• MalfunctionSep 7, 2018Retraction Problem

  IT WAS REPORTED THAT BD CATHENA¿ SAFETY IV CATHETER EXHIBITED RETRACTION FAILURE. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7857539 ↗
• MalfunctionSep 7, 2018Retraction Problem

  IT WAS REPORTED THAT BD CATHENA¿ SAFETY IV CATHETER EXHIBITED RETRACTION FAILURE. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7857513 ↗
• MalfunctionSep 7, 2018Retraction Problem

  IT WAS REPORTED THAT BD CATHENA¿ SAFETY IV CATHETER EXHIBITED RETRACTION FAILURE. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7857485 ↗